23 results on '"Hegazy, Maha A."'
Search Results
2. Evaluation of the efficiency of continuous wavelet transform as processing and preprocessing algorithm for resolution of overlapped signals in univariate and multivariate regression analyses; an application to ternary and quaternary mixtures.
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Hegazy, Maha A., Lotfy, Hayam M., Mowaka, Shereen, and Mohamed, Ekram Hany
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WAVELET transforms , *ALGORITHMS , *SIGNAL processing , *UNIVARIATE analysis , *REGRESSION analysis , *MIXTURES , *LEAST squares - Abstract
Wavelets have been adapted for a vast number of signal-processing applications due to the amount of information that can be extracted from a signal. In this work, a comparative study on the efficiency of continuous wavelet transform (CWT) as a signal processing tool in univariate regression and a pre-processing tool in multivariate analysis using partial least square (CWT-PLS) was conducted. These were applied to complex spectral signals of ternary and quaternary mixtures. CWT-PLS method succeeded in the simultaneous determination of a quaternary mixture of drotaverine (DRO), caffeine (CAF), paracetamol (PAR) and p -aminophenol (PAP, the major impurity of paracetamol). While, the univariate CWT failed to simultaneously determine the quaternary mixture components and was able to determine only PAR and PAP, the ternary mixtures of DRO, CAF, and PAR and CAF, PAR, and PAP. During the calculations of CWT, different wavelet families were tested. The univariate CWT method was validated according to the ICH guidelines. While for the development of the CWT-PLS model a calibration set was prepared by means of an orthogonal experimental design and their absorption spectra were recorded and processed by CWT. The CWT-PLS model was constructed by regression between the wavelet coefficients and concentration matrices and validation was performed by both cross validation and external validation sets. Both methods were successfully applied for determination of the studied drugs in pharmaceutical formulations. [ABSTRACT FROM AUTHOR]
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- 2016
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3. Novel pure component contribution, mean centering of ratio spectra and factor based algorithms for simultaneous resolution and quantification of overlapped spectral signals: An application to recently co-formulated tablets of chlorzoxazone, aceclofenac and paracetamol
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Toubar, Safaa S., Hegazy, Maha A., Elshahed, Mona S., and Helmy, Marwa I.
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CHLORZOXAZONE , *ACETAMINOPHEN , *SPECTRUM analysis , *UNIVARIATE analysis , *MULTIVARIATE analysis - Abstract
In this work, resolution and quantitation of spectral signals are achieved by several univariate and multivariate techniques. The novel pure component contribution algorithm (PCCA) along with mean centering of ratio spectra (MCR) and the factor based partial least squares (PLS) algorithms were developed for simultaneous determination of chlorzoxazone (CXZ), aceclofenac (ACF) and paracetamol (PAR) in their pure form and recently co-formulated tablets. The PCCA method allows the determination of each drug at its λ max . While, the mean centered values at 230, 302 and 253 nm, were used for quantification of CXZ, ACF and PAR, respectively, by MCR method. Partial least-squares (PLS) algorithm was applied as a multivariate calibration method. The three methods were successfully applied for determination of CXZ, ACF and PAR in pure form and tablets. Good linear relationships were obtained in the ranges of 2–50, 2–40 and 2–30 μg mL − 1 for CXZ, ACF and PAR, in order, by both PCCA and MCR, while the PLS model was built for the three compounds each in the range of 2–10 μg mL − 1 . The results obtained from the proposed methods were statistically compared with a reported one. PCCA and MCR methods were validated according to ICH guidelines, while PLS method was validated by both cross validation and an independent data set. They are found suitable for the determination of the studied drugs in bulk powder and tablets. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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4. Evaluation of multivariate calibration models with different pre-processing and processing algorithms for a novel resolution and quantitation of spectrally overlapped quaternary mixture in syrup.
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Moustafa, Azza A., Hegazy, Maha A., Mohamed, Dalia, and Ali, Omnia
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ALGORITHMS , *CALIBRATION , *ALGEBRA , *MATHEMATICAL programming , *PHYSICAL measurements - Abstract
A novel approach for the resolution and quantitation of severely overlapped quaternary mixture of carbinoxamine maleate (CAR), pholcodine (PHL), ephedrine hydrochloride (EPH) and sunset yellow (SUN) in syrup was demonstrated utilizing different spectrophotometric assisted multivariate calibration methods. The applied methods have used different processing and pre-processing algorithms. The proposed methods were partial least squares (PLS), concentration residuals augmented classical least squares (CRACLS), and a novel method; continuous wavelet transforms coupled with partial least squares (CWT-PLS). These methods were applied to a training set in the concentration ranges of 40–100 μg/mL, 40–160 μg/mL, 100–500 μg/mL and 8–24 μg/mL for the four components, respectively. The utilized methods have not required any preliminary separation step or chemical pretreatment. The validity of the methods was evaluated by an external validation set. The selectivity of the developed methods was demonstrated by analyzing the drugs in their combined pharmaceutical formulation without any interference from additives. The obtained results were statistically compared with the official and reported methods where no significant difference was observed regarding both accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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5. Validated spectrophotometric methods for simultaneous determination of Omeprazole, Tinidazole and Doxycycline in their ternary mixture.
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Lotfy, Hayam M., Hegazy, Maha A., Mowaka, Shereen, and Mohamed, Ekram Hany
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SPECTROPHOTOMETRY , *OMEPRAZOLE , *DOXYCYCLINE , *TERNARY system , *AMPLITUDE estimation - Abstract
A comparative study of smart spectrophotometric techniques for the simultaneous determination of Omeprazole (OMP), Tinidazole (TIN) and Doxycycline (DOX) without prior separation steps is developed. These techniques consist of several consecutive steps utilizing zero/or ratio/or derivative spectra. The proposed techniques adopt nine simple different methods, namely direct spectrophotometry, dual wavelength, first derivative-zero crossing, amplitude factor, spectrum subtraction, ratio subtraction, derivative ratio-zero crossing, constant center, and successive derivative ratio method. The calibration graphs are linear over the concentration range of 1–20 μg/mL, 5–40 μg/mL and 2–30 μg/mL for OMP, TIN and DOX, respectively. These methods are tested by analyzing synthetic mixtures of the above drugs and successfully applied to commercial pharmaceutical preparation. The methods that are validated according to the ICH guidelines, accuracy, precision, and repeatability, were found to be within the acceptable limits. [ABSTRACT FROM AUTHOR]
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- 2016
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6. A novel pure component contribution algorithm (PCCA) for extracting components’ contribution from severely overlapped signals; an application to UV-spectrophotometric data.
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Hegazy, Maha Abdel Monem
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EXTRACTION (Chemistry) , *ULTRAVIOLET spectrophotometry , *RANDOM noise theory , *IBUPROFEN , *BINARY mixtures , *ATENOLOL - Abstract
A novel, simple and accurate algorithm capable of extracting the contribution of each component from a mixture signal where the components are completely overlapped was developed. It is based on the development of a coded function which eliminates the signal of interfering components using mean centering as a processing tool; finally the pure contribution of each component is extracted. The algorithm allows the determination of each component as a single one. It was validated by the use of simulated data set of three overlapped signals and tested against simulated random noise. Two fit values were developed and calculated for optimization, one to test that that the absorptivity values of the extracted spectra are within the confidence limits of the slope and the other is the correlation between the pure and extracted spectra. It has been successfully applied to real UV data of binary mixture of Ibuprofen and Paracetamol and ternary mixture of Amiloride hydrochloride, Atenolol and Hydrochlorothiazide in tablets and capsules, respectively. The results were compared to previously reported separation method and no significant difference was found regarding both accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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7. Conventional univariate versus multivariate spectrophotometric assisted techniques for simultaneous determination of perindopril arginin and amlodipine besylate in presence of their degradation products.
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Hegazy, Maha A., Abbas, Samah S., Zaazaa, Hala E., and Essam, Hebatallah M.
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SPECTROPHOTOMETRY , *UNIVARIATE analysis , *ARGININE , *AMLODIPINE , *CHEMICAL decomposition , *OPACITY (Optics) , *LEAST squares - Abstract
The resolving power of spectrophotometric assisted mathematical techniques were demonstrated for the simultaneous determination of perindopril arginin (PER) and amlodipine besylate (AML) in presence of their degradation products. The conventional univariate methods include the absorptivity factor method (AFM) and absorption correction method (ACM), which were able to determine the two drugs, simultaneously, but not in the presence of their degradation products. In both methods, amlodipine was determined directly at 360 nm in the concentration range of 8–28 μg mL −1 , on the other hand perindopril was determined by AFM at 222.2 nm and by ACM at 208 nm in the concentration range of 10–70 μg mL −1 . Moreover, the applied multivariate calibration methods were able for the determination of perindopril and amlodipine in presence of their degradation products using concentration residuals augmented classical least squares (CRACLS) and partial least squares (PLS). The proposed multivariate methods were applied to 19 synthetic samples in the concentration ranges of 60–100 μg mL −1 perindopril and 20–40 μg mL −1 amlodipine. Commercially available tablet formulations were successfully analysed using the developed methods without interference from other dosage form additives except PLS model, which failed to determine both drugs in their pharmaceutical dosage form. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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8. Comparative study of novel versus conventional two-wavelength spectrophotometric methods for analysis of spectrally overlapping binary mixture.
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Lotfy, Hayam M., Hegazy, Maha A., Rezk, Mamdouh R., and Omran, Yasmin Rostom
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COMPARATIVE studies , *SPECTROPHOTOMETRY , *BINARY mixtures , *CHLORAMPHENICOL , *PREDNISOLONE , *ACETATES analysis - Abstract
Smart spectrophotometric methods have been applied and validated for the simultaneous determination of a binary mixture of chloramphenicol (CPL) and prednisolone acetate (PA) without preliminary separation. Two novel methods have been developed; the first method depends upon advanced absorbance subtraction (AAS), while the other method relies on advanced amplitude modulation (AAM); in addition to the well established dual wavelength (DW), ratio difference (RD) and constant center coupled with spectrum subtraction (CC–SS) methods. Accuracy, precision and linearity ranges of these methods were determined. Moreover, selectivity was assessed by analyzing synthetic mixtures of both drugs. The proposed methods were successfully applied to the assay of drugs in their pharmaceutical formulations. No interference was observed from common additives and the validity of the methods was tested. The obtained results have been statistically compared to that of official spectrophotometric methods to give a conclusion that there is no significant difference between the proposed methods and the official ones with respect to accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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9. Novel spectrophotometric methods for simultaneous determination of Amlodipine, Valsartan and Hydrochlorothiazide in their ternary mixture.
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Lotfy, Hayam M., Hegazy, Maha A., Mowaka, Shereen, and Mohamed, Ekram Hany
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SPECTROPHOTOMETRY , *AMLODIPINE , *VALSARTAN , *HYDROCHLOROTHIAZIDE , *TERNARY system , *SPECTRUM analysis - Abstract
This work represents a comparative study of two smart spectrophotometric techniques namely; successive resolution and progressive resolution for the simultaneous determination of ternary mixtures of Amlodipine (AML), Hydrochlorothiazide (HCT) and Valsartan (VAL) without prior separation steps. These techniques consist of several consecutive steps utilizing zero and/or ratio and/or derivative spectra. By applying successive spectrum subtraction coupled with constant multiplication method, the proposed drugs were obtained in their zero order absorption spectra and determined at their maxima 237.6 nm, 270.5 nm and 250 nm for AML, HCT and VAL, respectively; while by applying successive derivative subtraction they were obtained in their first derivative spectra and determined at P 230.8–246 , P 261.4–278.2 , P 233.7–246.8 for AML, HCT and VAL respectively. While in the progressive resolution, the concentrations of the components were determined progressively from the same zero order absorption spectrum using absorbance subtraction coupled with absorptivity factor methods or from the same ratio spectrum using only one divisor via amplitude modulation method can be used for the determination of ternary mixtures using only one divisor where the concentrations of the components are determined progressively. The proposed methods were checked using laboratory-prepared mixtures and were successfully applied for the analysis of pharmaceutical formulation containing the cited drugs. Moreover comparative study between spectrum addition technique as a novel enrichment technique and a well established one namely spiking technique was adopted for the analysis of pharmaceutical formulations containing low concentration of AML. The methods were validated as per ICH guidelines where accuracy, precision and specificity were found to be within their acceptable limits. The results obtained from the proposed methods were statistically compared with the reported one where no significant difference was observed. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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10. Mean centering of ratio spectra and concentration augmented classical least squares in a comparative approach for quantitation of spectrally overlapped bands of antihypertensives in formulations.
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Hegazy, Maha Abdel Monem and Fayez, Yasmin Mohammed
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SPECTRUM analysis , *LEAST squares , *COMPARATIVE studies , *ANTIHYPERTENSIVE agents , *SPECTROPHOTOMETRY , *DATA analysis - Abstract
Two different methods manipulating spectrophotometric data have been developed, validated and compared. One is capable of removing the signal of any interfering components at the selected wavelength of the component of interest (univariate). The other includes more variables and extracts maximum information to determine the component of interest in the presence of other components (multivariate). The applied methods are smart, simple, accurate, sensitive, precise and capable of determination of spectrally overlapped antihypertensives; hydrochlorothiazide (HCT), irbesartan (IRB) and candesartan (CAN). Mean centering of ratio spectra (MCR) and concentration residual augmented classical least-squares method (CRACLS) were developed and their efficiency was compared. CRACLS is a simple method that is capable of extracting the pure spectral profiles of each component in a mixture. Correlation was calculated between the estimated and pure spectra and was found to be 0.9998, 0.9987 and 0.9992 for HCT, IRB and CAN, respectively. The methods were successfully determined the three components in bulk powder, laboratory-prepared mixtures, and combined dosage forms. The results obtained were compared statistically with each other and to those of the official methods. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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11. Novel spectrophotometric determination of chloramphenicol and dexamethasone in the presence of non labeled interfering substances using univariate methods and multivariate regression model updating.
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Hegazy, Maha A., Lotfy, Hayam M., Rezk, Mamdouh R., and Omran, Yasmin Rostom
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SPECTROPHOTOMETRY , *CHLORAMPHENICOL , *DEXAMETHASONE , *UNIVARIATE analysis , *REGRESSION analysis , *BINARY mixtures - Abstract
Smart and novel spectrophotometric and chemometric methods have been developed and validated for the simultaneous determination of a binary mixture of chloramphenicol (CPL) and dexamethasone sodium phosphate (DSP) in presence of interfering substances without prior separation. The first method depends upon derivative subtraction coupled with constant multiplication. The second one is ratio difference method at optimum wavelengths which were selected after applying derivative transformation method via multiplying by a decoding spectrum in order to cancel the contribution of non labeled interfering substances. The third method relies on partial least squares with regression model updating. They are so simple that they do not require any preliminary separation steps. Accuracy, precision and linearity ranges of these methods were determined. Moreover, specificity was assessed by analyzing synthetic mixtures of both drugs. The proposed methods were successfully applied for analysis of both drugs in their pharmaceutical formulation. The obtained results have been statistically compared to that of an official spectrophotometric method to give a conclusion that there is no significant difference between the proposed methods and the official ones with respect to accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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12. A novel spectral resolution and simultaneous determination of multicomponent mixture of Vitamins B1, B6, B12, Benfotiamine and Diclofenac in tablets and capsules by derivative and MCR–ALS.
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Hegazy, Maha A, Abdelwahab, Nada S, and Fayed, Ahmed S
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SPECTRUM analysis , *VITAMINS , *MULTIPHASE flow , *DICLOFENAC , *COMPARATIVE studies , *HIGH performance liquid chromatography - Abstract
A novel method was developed for spectral resolution and further determination of five-component mixture including Vitamin B complex (B1, B6, B12 and Benfotiamine) along with the commonly co-formulated Diclofenac. The method is simple, sensitive, precise and could efficiently determine the five components by a complementary application of two different techniques. The first is univariate second derivative method that was successfully applied for determination of Vitamin B12. The second is Multivariate Curve Resolution using the Alternating Least Squares method (MCR–ALS) by which an efficient resolution and quantitation of the quaternary spectrally overlapped Vitamin B1, Vitamin B6, Benfotiamine and Diclofenac sodium were achieved. The effect of different constraints was studied and the correlation between the true spectra and the estimated spectral profiles were found to be 0.9998, 0.9983, 0.9993 and 0.9933 for B1, B6, Benfotiamine and Diclofenac, respectively. All components were successfully determined in tablets and capsules and the results were compared to HPLC methods and they were found to be statistically non-significant. [ABSTRACT FROM AUTHOR]
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- 2015
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13. Two and three way spectrophotometric-assisted multivariate determination of linezolid in the presence of its alkaline and oxidative degradation products and application to pharmaceutical formulation.
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Hegazy, Maha Abd El-Monem, Eissa, Maya Shaaban, Abd El-Sattar, Osama Ibrahim, and Abd El-Kawy, Mohammad
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LINEZOLID , *ALKALINE solutions , *OXIDATION , *DRUG development , *CHROMATOGRAPHIC analysis , *ULTRAVIOLET spectrophotometry - Abstract
Highlights: [•] Most of reported methods of LIN are based on chromatographic technique. [•] Chromatographic methods are relatively of high cost and consuming time. [•] Multivariate calibration, based on UV spectrophotometric data was used. [•] It is suitable method for an accurate, rapid and less expensive determination. [•] Several methods were simultaneously determine LIN and its degradation products. [Copyright &y& Elsevier]
- Published
- 2014
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14. Novel spectrophotometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture.
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Lotfy, Hayam Mahmoud, Hegazy, Maha A., Rezk, Mamdouh R., and Omran, Yasmin Rostom
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PROPANOLAMINES , *DRUG analysis , *SPECTROPHOTOMETRY , *ABSORPTION , *AMPLITUDE modulation , *COMPUTER software - Abstract
Highlights: [•] Two novel methods namely; absorbance subtraction (AS) and amplitude modulation (AM) methods were developed. [•] Six recently well established spectrophotometric methods (SRS, RD, RS, EXRS, CM and MCR) were applied. [•] The proposed methods are very simple, accurate, precise. [•] They do not require any sophisticated apparatus or computer programs. [ABSTRACT FROM AUTHOR]
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- 2014
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15. Univariate versus multivariate spectrophotometric methods for the simultaneous determination of omarigliptin and two of its degradation products.
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Kelani, Khadiga M., Hegazy, Maha A., Hassan, Amal M., and Tantawy, Mahmoud A.
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ARTIFICIAL neural networks , *DRUG tablets , *PARTIAL least squares regression , *SUBTRACTION (Mathematics) - Abstract
[Display omitted] • Omarigliptin was liable to hydrolytic and oxidative degradations. • Novel stability indicating spectrophotometric methods were developed. • Four univariate and two multivariate approaches were adopted. • Validation was conducted as per ICH guidelines. Six selective spectrophotometric techniques, four univariate and two multivariate ones were developed for the determination of the antidiabetic drug omarigliptin (OMR) along with its hydrolytic and oxidative degradation products. The proposed univariate spectrophotometric methods were ratio subtraction, first derivative, derivative ratio and ratio difference. Linearities were constructed in the range of 10.0–180.0 μg mL−1 for both OMR & its hydrolytic degradation product and 10.0–110.0 μg mL−1 for the oxidative degradation one. On the other hand, partial least squares and artificial neural networks were the chosen multivariate approaches. Their linearity ranges were 20.0–60.0 μg mL−1 for OMR and 10.0–30.0 μg mL−1 for the two degradation products. All the methods were validated, effectively applied for quantification of the intact drug in its tablet formulation and favorably compared to the reported one. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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16. Simultaneous determination of some cholesterol-lowering drugs in their binary mixture by novel spectrophotometric methods.
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Lotfy, Hayam Mahmoud and Hegazy, Maha Abdel Monem
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CHOLESTEROL in the body , *BINARY mixtures , *SPECTROPHOTOMETERS , *HIGH performance liquid chromatography , *DRUG dosage , *SEPARATION (Technology) - Abstract
Highlights: [•] Smart, novel and simple spectrophotometric methods were successfully applied. [•] They are used for simultaneous analysis of complex binary and ternary mixtures. [•] They do not need a special program and could be easily applied in QC labs. [•] They are having equal accuracy, precision and lower cost compared to HPLC methods. [•] They are used for analysis of dosage form without any preliminary separation step. [Copyright &y& Elsevier]
- Published
- 2013
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17. Development of distribution maps of spectrally similar degradation products by Raman chemical imaging microscope coupled with a new variable selection technique and SIMCA classifier.
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Saleh, Ahmed A., Hegazy, Maha, Abbas, Samah, and Elkosasy, Amira
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ASPIRIN , *SALICYLIC acid , *REGULATORY approval , *MANUFACTURING processes , *CHEMOMETRICS , *MICROSCOPES - Abstract
[Display omitted] • Distribution Maps. • Variables Strength Coefficient VSC. • Raman-CI Microscope. • SIMCA. The ability to detect degradation products of active pharmaceutical ingredients (API) is an essential performance not only for conducting proper stability studies and subsequently gain regulatory approvals; but as well for detecting degradation products during the manufacturing process (In Process Control). Thus, this study aims to present the ability of using Raman Chemical Imaging (Raman-CI) microscope, with its optimum precision, in combination with appropriate chemometrics algorithms, to detect the spectrally similar Salicylic Acid (SA) in Acetylsalicylic Acid (ASA) powder mixture, and then create a chemical distribution map that reflects the distribution of ASA's main degradation product. The generated Hyperspectral images were processed where, a supervised chemometrics soft classifier, Soft Independent Modeling of Class Analogy (SIMCA), is applied to classify pixels and construct the subsequent distribution maps. In addition, due to the challenge of the high structural and spectral similarity between both substances, this study presents a new variable selection and dimensionality reduction technique, called Variable Strength Coefficient (VSC) to maximize the spectral differences and enhance the model precision and selectivity. A High-performance liquid chromatographic (HPLC) method was applied as a reference separation method to assess the results obtained by the proposed technique. The proposed technique was validated, where the obtained results confirmed that Raman Chemical Imaging Microscope, when coupled with SIMCA and VSC, is a powerful tool with outstanding accuracy. In addition, this approach could be suitable in applications where constructing accurate distribution maps of spectrally similar API's is required. [ABSTRACT FROM AUTHOR]
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- 2022
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18. Univariate and multivariate assisted spectrophotometric methods for determination of rosuvastatin calcium and fenofibrate in bulk powders and tablets along with their degradation products.
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Hegazy, Maha A., Bakr, Maryam A., Badawey, Amr M., and Abbas, Samah S.
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ROSUVASTATIN , *FENOFIBRATE , *PARTIAL least squares regression , *STANDARD deviations , *LATENT variables - Abstract
• No reported spectrophotometric method for determination of this quaternary mixture. • The proposed univariate methods utilize simple mathematical calculation. • Multivariate methods surpass univariate methods in solving severe overlap spectra. • Multivariate models have the advantage of being stability indicating methods. Rosuvastatin calcium and fenofibrate are recently co-formulated for treatment of hyperlipidemia. Two selective spectrophotometric approaches were developed, the first is univariate manipulation of spectrophotometric data, where isoabsorptive point and dual wavelength method were applied. The total concentration of rosuvastatin calcium and fenofibrate could be determined at λ = 253.2 nm while rosuvastatin calcium was determined with dual wavelength (λ = 243.5 and 307.9 nm) where linearity was achieved in the range of 2.00–22.00 µg/mL and mean accuracy 100.29 ± 0.568 then, by difference, Fenofibrate was determined in the range of 2.00–22.00 µg/mL and mean accuracy 100.23 ± 0.578. The second approach is a stability indicating multivariate modeling namely principal component regression and partial least squares, where the two drugs were determined in the presence of their degradation products. 17 samples were prepared according to five levels four factors calibration design. The developed models were described by 4 latent variables, and good prediction was evidenced by low root mean square error of prediction. The proposed methods were found to be rapid and simple and required no preliminary separation. Rosuvastatin calcium and fenofibrate were analyzed with mean recoveries 99.54 ± 0.903, 99.88 ± 0.548 and 99.50 ± 0.712, 99.30 ± 0.802, respectively. The two drugs were successfully determined in tablets by the developed methods and the results were compared to HPLC methods, where they were found to be statistically non-significant. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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19. Spectral signal processing approaches for selective quantification of the recently FDA approved brand-new combination of Vaborbactam and Meropenem; for conformity assessment of bulk and batch release.
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Awan, Zuhier Ahmed, Hegazy, Maha A., and Kammoun, Ahmed K.
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SIGNAL processing , *SIGNAL filtering , *URINARY tract infections , *CONFORMITY , *MEROPENEM - Abstract
Vaborbactam (VBR) and Meropenem (MRP) is a recently approved combination for treatment of complicated urinary tract infection (cUTI). Three different signal processing approaches utilizing UV spectral data has been applied for quality assessment of Vabromere® injection. First, the simplest signal processing method, dual wavelength (DW) was developed, where VBR and MRP were determined at (234.0 & 291.0 nm) and (219.5 & 245.5 nm), respectively. The second one utilized signal processing through derivatization, where, each drug was determined without any interference. This was achieved at 250.0 & 318.0 nm for VBR and MRP, respectively. The third approach is the recently developed algorithm, pure component contribution (PCCA), which efficiently extracts the pure spectrum of each drug and therefore determination is achieved at their λ max with maximum sensitivity and lowest error. The applied methods were found to be linear in the concentration range of 5.00–100.00 μg/mL and 5.00–150.00 μg/mL, for VBR and MRP, respectively. Minimum solvent consumption and diminished preparation or extraction steps are achieved associated with accurate quantitation of VBR and MRP in bulk powders and injection. The developed methods were successfully compared to a reported HPLC method, where no significant difference was found regarding both accuracy and precision. Unlabelled Image • The co-formulation has been recently approved by FDA. • No reported spectrophotometric methods for their determination. • Simple methods were developed targeted for application in QC labs. • Different signal filtering techniques have been applied overcoming both systematic and random errors. • The developed methods are highly efficient and are considered comparable to HPLC. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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20. Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form.
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Khattab, Fatma I., Ramadan, Nesrin K., Hegazy, Maha A., Al-Ghobashy, Medhat A., and Ghoniem, Nermine S.
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SPECTROPHOTOMETRY , *CHEMICAL derivatives , *BULK solids , *METAL powders , *DENSITY functional theory - Abstract
Four simple, accurate, sensitive and precise spectrophotometric methods were developed and validated for simultaneous determination of Troxerutin (TXN) and Carbazochrome (CZM) in their bulk powders, laboratory prepared mixtures and pharmaceutical dosage forms. Method A is first derivative spectrophotometry ( D 1 ) where TXN and CZM were determined at 294 and 483.5 nm, respectively. Method B is first derivative of ratio spectra (DD 1 ) where the peak amplitude at 248 for TXN and 439 nm for CZM were used for their determination. Method C is ratio subtraction (RS); in which TXN was determined at its λ max (352 nm) in the presence of CZM which was determined by D 1 at 483.5 nm. While, method D is mean centering of the ratio spectra (MCR) in which the mean centered values at 300 nm and 340.0 nm were used for the two drugs in a respective order. The two compounds were simultaneously determined in the concentration ranges of 5.00–50.00 μg mL −1 and 0.5–10.0 μg mL −1 for TXN and CZM, respectively. The methods were validated according to the ICH guidelines and the results were statistically compared to the manufacturer’s method. [ABSTRACT FROM AUTHOR]
- Published
- 2015
- Full Text
- View/download PDF
21. Evaluating the efficiency of spectral resolution of univariate methods manipulating ratio spectra and comparing to multivariate methods: An application to ternary mixture in common cold preparation.
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Moustafa, Azza Aziz, Salem, Hesham, Hegazy, Maha, and Ali, Omnia
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CHLORPHENIRAMINE , *DRUG tablets , *CHEMICAL sample preparation , *TERNARY alloys , *MIXTURES , *PHARMACEUTICAL chemistry , *MULTIVARIATE analysis - Abstract
Simple, accurate, and selective methods have been developed and validated for simultaneous determination of a ternary mixture of Chlorpheniramine maleate (CPM), Pseudoephedrine HCl (PSE) and Ibuprofen (IBF), in tablet dosage form. Four univariate methods manipulating ratio spectra were applied, method A is the double divisor-ratio difference spectrophotometric method (DD-RD). Method B is double divisor-derivative ratio spectrophotometric method (DD-RD). Method C is derivative ratio spectrum-zero crossing method (DRZC), while method D is mean centering of ratio spectra (MCR). Two multivariate methods were also developed and validated, methods E and F are Principal Component Regression (PCR) and Partial Least Squares (PLSs). The proposed methods have the advantage of simultaneous determination of the mentioned drugs without prior separation steps. They were successfully applied to laboratory-prepared mixtures and to commercial pharmaceutical preparation without any interference from additives. The proposed methods were validated according to the ICH guidelines. The obtained results were statistically compared with the official methods where no significant difference was observed regarding both accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2015
- Full Text
- View/download PDF
22. Spectrophotometric methods for determination of glimepiride and pioglitazone hydrochloride mixture and application in their pharmaceutical formulation.
- Author
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Ghoniem, Nermine S., Hussien, Emad M., Atta, Madonna Y., and Hegazy, Maha A.
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SPECTROPHOTOMETRY , *BEER-Lambert law , *PIOGLITAZONE , *POWDERS - Abstract
[Display omitted] • The developed methods are simple, accurate, and precise spectrophotometric methods. • Four methods were used simultaneous determination of glimepiride and pioglitazone hydrochloride. • The methods were successfully applied for the determination of glimepiride and pioglitazone hydrochloride in pure powder and dosage form. • The results obtained were compared statistically with the official one. Simple, accurate, and precise four spectrophotometric methods were developed and validated for simultaneous determination of glimepiride and pioglitazone hydrochloride in their pharmaceutical formulation. The first spectrophotometric method was the dual-wavelength which determined glimepiride at 219.0 and 228.0 nm and pioglitazone hydrochloride at 268.0 nm. The second one is the first derivative of ratio spectra (DD1) spectrophotometry in which the peak amplitudes were used at 238.0 nm and 268.0 nm for glimepiride and pioglitazone hydrochloride, respectively. The third method is ratio subtraction in which glimepiride was determined at 228.0 nm in the presence of pioglitazone hydrochloride which was determined by extended ratio subtraction at 268.0 nm. The fourth method was the ratio difference to determine glimepiride and pioglitazone hydrochloride. Beer's law was confirmed in the concentration range 2.50–15.00 µg mL-1, and 10.00–50.00 µg mL-1 for glimepiride and pioglitazone respectively for the four methods. The proposed methods were used to determine both drugs in their pure powdered form with mean percentage recoveries of 99.91 ± 1.117% for glimepiride and 99.76 ± 0.911% for pioglitazone hydrochloride in method (A). In method (B), the mean percentage recoveries were 100.12 ± 0.89% for glimepiride and 100.02 ± 1.06% for pioglitazone hydrochloride. In method (C) glimepiride was 100.01 ± 0.592% and 99.85 ± 0.845% for pioglitazone hydrochloride by extended ratio subtraction. And finally, in method (D) the mean percentage recoveries were 100.66 ± 0.670% for glimepiride and 99.92 ± 0.988% for pioglitazone hydrochloride. The developed methods were successfully applied for the determination of glimepiride and pioglitazone hydrochloride in pure powder and dosage form. The suggested methods were also used to determine both compounds in laboratory-prepared mixtures. The accuracy, precision, and linearity ranges of the developed methods were determined. The results obtained were compared statistically with the official method, and there was no significant difference between the proposed methods and the official method for accuracy and precision. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
23. Bilinear and trilinear algorithms utilizing full and selected variables for resolution and quantitation of four components with overlapped spectral signals in bulk and syrup dosage form.
- Author
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Boltia, Shereen A., Fayed, Ahmed S., Musaed, Awadh, and Hegazy, Maha A.
- Subjects
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FEATURE selection , *DRUG dosage , *STANDARD deviations , *GENETIC algorithms , *SYRUPS , *ALGORITHMS - Abstract
Spectrophotometric-assisted chemometric techniques are beneficial for resolving spectral overlapping and are considered comparable to traditional chromatographic methods. In this work, different chemometric approaches were applied for simultaneous determination of Bromhexine HCl (BRHX), Guaifenesin (GUA) and Salbutamol sulphate (SALB) in the presence of Guaiacol (GUAIA), without any prior separation. Two-way and three-way techniques were applied. The resolving power of genetic algorithm (GA-PLS), trilinear partial least square (N-PLS) and multivariate curve resolution (MCR-ALS) were investigated. A set of 17 synthetic samples in the concentration range 10.0–30.0 μg/mL of BRHX, GUA and SALB and 6.0–10.0 μg/mL of GUAIA were used in the construction of the calibration models. Commercially available syrup dosage form was successfully analyzed by the developed methods without interference from formulation additives. The developed models were evaluated through calculation of root mean squared error of prediction (RMSEP), the obtained values were 0.263, 0.419 and 0.342 for BRHX, 0.254, 0.318 and 0.503 for GUA and 0.298, 0.268 and 0.302 for SALB using N-PLS, MCR-ALS and GA-PLS, respectively. The resolving power of the developed models was emphasized through comparison with a reported HPLC method, where no significant difference was found regarding both accuracy and precision. Unlabelled Image • Three chemometric methods were developed to resolve the spectral overlap of three coformulated drugs with listed impurity. • Wavelength selection and use of trilinear data greatly enhance the efficiency of multivariate calibration methods. • Genetic Algorithms as a feature selection technique to spectral data for selecting the most informative variables was applied. • Two different trilinear algorithms; N-PLS & MCR-ALS were applied for the purpose of comparison. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
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