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A derivative UV spectrophotometric and a reversed phase high-performance liquid chromatographic method for determination of ciprofibrate in tablets was developed. The first-order derivative UV spectrophotometric method found to be accurate with 100.57±0.97 recovery and precise with a coefficient of variation of 1.44. These results were compared to those obtained by reference methods, zero-order UV spectrophotometric method and a reversed-phase high-performance liquid chromatography method. A reversed-phase C8 column with methanol:water (90:10, pH 3.7) mobile phase was used and the detector wavelength was set at 232 nm. Calibration solutions used in HPLC were ranging from 2 to 12 µg/ml. An ANOVA test (P = 0.0226, F = 4.935) showed that the results obtained with the derivative UV spectrophotometric method were comparable to those obtained using reference methods. [ABSTRACT FROM AUTHOR]

A simple, selective, precise high-performance thin-layer chromatographic method for simultaneous determination of amlodipine besylate and metoprolol succinate in bulk and pharmaceutical combined dosage form was developed and validated. The method employed HPTLC aluminum plates precoated with silica gel 60F-254 (10x10) as the stationary phase. The solvent system consisted of toluene:ethyl acetate:methanol:triethylamine (4:1:1:0.4 v/v/v). The system was found to give a compact spot for amlodipine besylate (Rf = 0.39±0.02) and metoprolol succinate (Rf = 0.59±0.02). Densitometric analysis of amlodipine besylate and metoprolol succinate was carried out in the absorbance mode at 254 nm. Linear regression analysis data for the calibration plots showed good linear relationship with r² = 0.9990±0.0013 with respect to peak area in the concentration range 400-1400 ng per spot for amlodipine besylate and r² = 0.9993±0.0013 with respect to peak area in the concentration range 3800-13300 ng per spot for metoprolol succinate. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 39.99 and 121.20 ng per spot for amlodipine besylate and 234.31 and 710.03 ng per spot for metoprolol succinate, respectively. Statistical analysis proved that the method is selective, precise and accurate for the estimation of amlodipine and metoprolol. [ABSTRACT FROM AUTHOR]

Aim: The aim of this work is to establish two simple, economical, and rapid spectrophotometric methods for the quantification of entacapone in bulk material and in tablets. Further, this study is designed to validate the developed methods as per ICH guidelines. Materials and Methods: In Methods I and II, a stock standard solution was prepared by dissolving 10 mg of entacapone in 100 mL of 10% v/v acetonitrile to obtain a concentration of 100 µg/mL. After suitable dilution, 10 µg/mL of entacapone was prepared and scanned in the UV-visible range 500-200 nm; entacapone showed a maximum absorbance at 384.40 nm. In Method I, area under curve (AUC) of the zero-order spectrum was recorded between 348.00 and 410.20 nm. While, in Method II, zero-order spectra were derivatized into first-order, and the AUC was recorded between 386.40 and 460.20 nm. For a linearity study, series of dilutions were prepared from stock solutions. Results: In Method I, and II, entacapone followed linearity in the concentration range of 2-12 µg/mL and 5-30 µg/mL with (r²>0.999). The amounts of entacapone estimated by both these methods were found to be 99.24 ± 0.054 and 98.68 ± 1.04, respectively. Conclusion: The developed methods are simple, precise, rugged, robust, and economical. Both these methods can be used for routine analysis of entacapone from its tablet formulation. [ABSTRACT FROM AUTHOR]

This paper describes the application of thin-layer chromatography ( TLC) combined with densitometry to simultaneous determination of levofloxacin hemihydrate ( LEV) and ambroxol hydrochloride ( AMB) in bulk and tablets. The separation was achieved on aluminum sheet of silica gel 60 F254 using chloroform: methanol: toluene: ammonia (10: 6: 3: 0.8 v/v/v/v) as mobile phase. Quantification was carried out densitometrically at 245 nm. This system was found to give compact spots for LEV ( Rf value of 0.4) and AMB ( Rf value of 0.7). The calibration curves for LEV and AMB was found to be linear between 9960–16600 ng/spot ( r2 = 0.999) and 600–1000 ng/spot ( r2 = 0.999), respectively. The mean percentage recoveries from tablets for LEV and AMB were 99.45% and 99.58%, respectively. The TLC-densitometry method has many advantages, such as simplicity, reasonable sensitivity, rapidity, and low cost, and it can be successfully used in routine analysis of both these drugs in tablet formulations. [ABSTRACT FROM AUTHOR]

Two new, simple, accurate and economical spectrophotometric methods have been developed for simultaneous estimation of drotaverine hydrochloride and mefenamic acid in two-component tablet formulation. The methods employed are, first derivative spectrophotometry, using zero crossing technique and multicomponent analysis. Both the drugs obey the Beer's law in the concentration range employed for these methods. The results of analysis are validated by statistical evaluation and recovery studies. [ABSTRACT FROM AUTHOR]

A reverse phase high performance liquid chromatography method was developed for simultaneous estimation of paracetamol and valdecoxib in tablet formulation. The separation was achieved by Luna C18 column and methanol: phosphate buffer pH 3.5 (60:40 v/v) as eluent, at a flow rate of 1.0 ml/min. Detection was carried out at 242 nm. Etoricoxib was used as an internal standard. The retention time of PAR and VAL was found to be 3.01 and 8.51 min, respectively. The method was validated for linearity, accuracy and precision. Linearity for paracetamol and valdecoxib were in the range 25-150 µg/ml and 1-6 µg/ml, respectively. The developed method was found to be accurate, precise, and selective for simultaneous estimation of paracetamol and valdecoxib in tablets. [ABSTRACT FROM AUTHOR]

A reverse phase high performance liquid chromatography method was developed for simultaneous estimation of tizanidine HCl and valdecoxib in tablet formulation. The separation was achieved by Luna C18 column and acetonitrile: phosphate buffer pH 3.5 (50:50 v/v) as eluent, at a flow rate of 0.5 ml/min. Detection was carried out at 227 nm. Etoricoxib was used as an internal standard. The retention time of tizanidine and valdecoxib was found to be 4.43 and 16.60 min, respectively. The method was validated for linearity, accuracy and precision. Linearity for tizanidine and valdecoxib were in the range 0.4-2.0 µg/ml and 4-20 µg/ml, respectively. The developed method was found to be accurate, precise and selective for simultaneous estimation of tizanidine and valdecoxib in tablets. [ABSTRACT FROM AUTHOR]

A simple, accurate, economical and reproducible procedure for simultaneous estimation of atorvastatin calcium and ezetimibe in their tablet dosage form has been developed using, Q-absorbance equation. The method involves, the absorbance measurement at 235.5 nm (iso-absorptive point) and 246.0 nm (λmax of atorvastatin calcium), in methanol. Both the drugs, obey Beer-Lambert's law in the concentration range of 5-25 µg/ml. The results of analysis have been validated statistically and by recovery studies. [ABSTRACT FROM AUTHOR]

A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for perindopril erbumine and indapamide in combination tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, linearity, accuracy, precision, range, robustness and solution stability studies. The dissolution method, which uses a USP apparatus 1 with basket rotating at 100 rpm, 1000 ml of phosphate buffer, pH 6.8, as the dissolution medium, and reversed-phased HPLC was carried out at 50 °C on a 4.6 mmx250 mmx5 µm cyano column that contained USP packing L1 with acetonitrile:buffer 40:60 (v/v), pH 2.8, as mobile phase. UV detector was set at 225 nm. The method was found to be selective, linear, accurate and precise in the specified ranges. Intra-day and inter--day variability for method was <2% RSD. This method was successfully used for quantification of perindopril erbumine and indapamide combination tablet formulations. [ABSTRACT FROM AUTHOR]

A stability-indicating RP-TLC/Densitometry method for analysis of Raloxifene hydrochloride both in bulk material and in tablets was developed and validated. Densitometric analysis of Raloxifene hydrochloride was carried out at 311 nm on TLC aluminium plates precoated with silica gel 60RP-18 F254S as the stationary phase and methanol :water : ammonia (95 : 05 : 0.1 v/v) as mobile phase. Raloxifene hydrochloride was well resolved at Rf 0.55 ± 0.02. The linear regression analysis data for the calibration plots showed good linear relationship with r² = 0.9969 ± 0.0015 with respect to peak area in the concentration range 100-600 ng per band. The mean value ± SD of slope and intercept was found to be 15.05 ± 0.44 and 201.9 ± 29.58 with respect to peak area. The limits of detection and quantification were 9.27 ng and 27.10 ng, respectively. Raloxifene hydrochloride was subjected to acid and alkali hydrolysis, oxidation, dry heat, and photodegradation. The drug underwent degradation under basic and oxidation conditions. This indicates that the drug is susceptible to alkali hydrolysis and oxidation. The proposed developed RPTLC/ Densitometry method can be applied for identification and quantitative determination of Raloxifene hydrochloride in bulk material and tablets. [ABSTRACT FROM AUTHOR]