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A simple, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Ertugliflozin (ETZ) and metformin (MFN) in bulk and in tablet dosage form. The method was carried out by used Waters (5µm, C18 250 x 4.6 mm) column with mobile phase consists of 0.75 mM sodium dihydrogen orthophosphate buffer pH adjusted to 8.5, with NaOH, and acetonitrile in the ratio of 60:40 v/v, a flow rate of 1.5 mL/min and photodiode detection at 263 nm. The method was validated as per ICH guidelines with different parameters, the mean retention times of ertugliflozin and metformin were found to be 3.5& 2.0 min, respectively. The correlation coefficient values of calibration curves were found to be 0.999 for both ETZ and MFN, respectively. The LOD and LOQ for ertugliflozin and metformin were found to be 0.02-0.06 µg/mL and 17.5-58.3 µg/mL respectively. [ABSTRACT FROM AUTHOR]

A selective, sensitive RP-HPLC method was developed for the simultaneous estimation of the Ertugliflozin (ETR) and Sitagliptin (SGT) in bulk and its dosage form. The separation and determination was carried on water's C18 column capacitate (250X4.6 mm, 5 µm particle size), retention times of Ertugliflozin and Sitagliptin were found to be 2.39 and 4.60 min. respectively. The wavelength was fixed at 215 nm with PDA detection. The mobile phase was consisted mixture of 0.5 mM potassium dihydrogen ortho phosphate buffer: Methanol in the ratio of 55:45 v/v, pH 5.3 was adjusted with HCl and flow of mobile phase was maintained 1mL/min. The calibration curve was linear and regression co-efficient (R²) value found to be 0.999 and concentration ranging from 37.5-112.5 and 250-750 µg/mL for Ertugliflozin and Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 µg/ml and 0.4 and 1µg/ml for Ertugliflozin and Sitagliptin. [ABSTRACT FROM AUTHOR]

Introduction: A simple and Rapid High Performance Liquid Chromatographic method was developed and validated for simultaneous estimation of lamivudine, tenofovir alafenamide and dolutegravir in their tablet dosage form. Method: The method was established using Agilent C18 (250 × 4.6 mm, i.d., 5 µm) column, a mobile phase consisting of 0.05M phosphate buffer pH 6.2 (solvent A) and acetonitrile (solvent B) 60:40 v/v at a flow rate of 1 mL/min with isocratic elution, injecting 10 µL sample into the chromatographic system. The eluted compounds were detected by using PDA Detector at a detection wavelength of 260 nm and the temperature was maintained at 30°C. Result: Retention times for the three compounds were found to be 3.09 min, 6.19 min and 9.61min for lamivudine, tenofovir alafenamide, and dolutegravir respectively. The linearity range was 10-80 µg/ml for three drugs with values of LOD found to be 0.56, 0.39µg, 1.35µg and LOQ were found to be 1.50µg, 0.99µg and 3.61 µg for lamivudine, tenofovir alafenamide and dolutegravir respectively which were linear enough showing correlation coefficient 0.999 in all the cases. Conclusion: The proposed method is therefore, suitable for the purpose in quality-control laboratories for quantitative analysis of the drugs individually and in the combined dosage form. The method was found to be as it is simple and rapid with tremendous precision and accuracy. The method can be used as a routine quality control method for triple combined dosage forms. [ABSTRACT FROM AUTHOR]

Background: A simple reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of the Pibrentasvir and Glecaprevir in bulk and its solid dosage form. Materials and Methods: The method was developed on water's C18 column capacitate 250X4.6 mm, 5 µm particle size, wavelength was fixed at 225 nm with photo diode array detection. The mobile phase was consisted mixture of 0.5 mM Ortho phosphoric acid buffer: Acetonitrile in the ratio of 75:25 v/v, pH 4.3 was adjusted with hydrochloric acid and flow of mobile phase through the column was maintained 1mL/min. Results: The retention times of Pibrentasvir and Glecaprevir were found to be 3.04 and 4.45 min respectively. The method was statistically validated with concern of precision, linearity, range and robustness of method was found for Pibrentasvir and Glecaprevir. The above method was afforded excellent percentage recovery was found to be 99.87-100.22% and 99.68-100.17% for Pibrentasvir and Glecaprevir respectively. The Limit of detection and Limit of quantification were found 0.12 and 0.43µg/mL and 0.008 and 0.027µg/mL for Pibrentasvir and Glecaprevir. The forced degradation studies were performed. Conclusion: The method was developed and validated for the estimation of Pibrentasvir and Glecaprevir. The method was sensitive, precise, accurate, and robust, showed good linearity with different concentrations. The method is used for the routine analysis of Pibrentasvir and Glecaprevir in its bulk and pharmaceutical dosage form. [ABSTRACT FROM AUTHOR]

Water is a universal solvent. In pharmaceutical industry, water plays a vital role in the formulation and manufacturing of many products. Different types of waters are used for different types of dosage forms (e.g.: water for injection, sterile water for injection, purified water, etc.). If microbial purification and validation of water handling systems is not proper, this may have effect on quality. To produce best quality products, frequent monitoring, maintenance and validation of water handling systems and all the Total Organic Carbon content, inorganic, organic and microbial limits must be in specified limits as per USP specifications. The present article describes the need for validation and maintenance of water to produce good quality products. [ABSTRACT FROM AUTHOR]