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.
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 215nm 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 & Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 µg/ml and 0.4&1µg/ml for Ertugliflozin & Sitagliptin.
A stability indicating RP HPLC method has been developed for the determination of gemcitabine hydrochloride. Chromatography was carried out on an ODS C18column (250×4.6 mm; 5μ) using a mixture of methanol and phosphate buffer (40: 60 v/v ) as the mobile phase at a flow rate of 1.0 mL/min. The detection of the drug was monitored at 270 nm. The retention time of the drug was found to be 2.31 min. The method produced linear responses in the concentration range of 10 to 60 μg/mL of gemcitabine HCl. The method was found to be reproducible for analysis of the drug in injectable dosage forms. The stability of the drug was assessed by forced degradation studies.
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