DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN BULK AND TABLET DOSAGE FORM

Abstract

A simple, accurate, sensitive reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the simultaneous estimation of the Sofosbuvir and Velpatasvirin bulk and tablet dosage form. Separation of the analytes was carried out by using Kromasil C18 (250 x 4.6mm, 5μm) column with HPLC grade methanol as mobile phase at aflow rate of 1.0mL/min within the run time of 4 min. The detection wavelength selected was 261nm for Sofosbuvir (SOF) and 303nm for Velpatasvir (VEL).The retention times of SOF and VEL were 2.57 min and 2.86 min, respectively. The linearity of the method was found in the concentration range of 2.0-40.0μg/mL for SOF and 2.0- 25.0μg/mL for VEL with correlation coefficient (R2) >0.99. The method was validated according to ICH guidelines. This method was also successfully employed for the simultaneous estimation of SOF and VEL in marketed formulation.