Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms
Journal Title: Indian Journal of Pharmaceutical and Biological Research - Year 2017, Vol 5, Issue 4
Abstract
Stability indicating RP-HPLC method was developed for the simultaneous quantitation of Sofosbuvir and Velpatasvir in its pharmaceutical dosage form and validated. The drugs were separated on Discovery C18 (150mm x 4.6mm, 5μ) column using 0.01N potassium dihydrogen phosphate buffer and acetonitrile (50:50%v/v) as mobile phase on isocratic mode. The mobile phase is pump into the column at flow rate of 1.0ml/min and column oven temperature is maintained at 30ºC. The drugs were detected at a wavelength 240nm. The retention time for Sofosbuvir and Velpatasvir were found to be 2.32min and 3.34min respectively. The developed method is validated in accordance with ICH guidelines. The method was found to be accurate, precise, specific and robust. The method obeys Beer’s law at a concentration range of 100μg/ml – 600μg/ml of Sofosbuvir and 25μg/ml – 150μg/ml of Velpatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs were found to be stable and less prone to degradation when they are subjected to various stress conditions.
Authors and Affiliations
Jahnavi Bandla| Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak, Telangana, India, S. Ganapaty| Department of Pharmacognosy and Phytochemistry, GITAM Institute of Pharmacy GITAM University, Rushikonda, Visakhapatnam, Andhra Pradesh, India
Keywords
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- EP ID EP15599
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