STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR, VELPATASAVIR AND VOXILAPREVIR IN A PHARMACEUTICAL FORMULATION BY UHPLC
Authors/Creators
- 1. 1Pharmaceutical Analysis and Quality Assurance Division, Sri Vishnu College Of Pharmacy, Bhimavaram-534261. 2Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnm-530003, India.
Description
A Precise, accurate, Robust, Rugged, Specific, Stability indicating RP-UHPLC method has been developed and validated for the estimation of anti viral drugs Sofosbuvir, Velpatasavir and Voxilaprevir in pharmaceutical dosage form(Tablets) was carried out on Agilent UHPLC with Acquity BEH C18 (50 x 3.0mm. 1.7μm) column with mobile phase contains 0.05% Orthophoshoric acid: Acetonitrile: Methanol (40:40:20) at a flow rate of 1.0mL/min, detection was carried out at 270nm. The retention time of the Sofosbuvir, Velpatasavir and Voxilaprevir 2.04, 3.50&5.37mins respectively. The method produces linear responses in the range of 200μg/mL to 600μg/mL for Sofosbuvir, 50μg/mL to 150μg/mL for Velpatasavir, 50μg/mL to 150μg/mL for Voxilaprevir with correlation coefficients(r2 1.00), The % Recoveries between 100.5 to 101.7 for Sofosbuvir , 99.0 to 99.9 for Velpatasavir and 100.3 to 101.1 Voxilaprevir. Peak purity was more than 0.999 of main peaks in all forced degraded samples.
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