Abstract

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

V. Mounika*, D. Siva Naik, Nagaraju Pappula and G. Indira Priyadarshini

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Abstract

A simple and precise method was developed for the simultaneous estimation of Sofosbuvir and Velpatasvir in tablet dosage form using HPLC. The retention times for Sofosbuvir and Velpatasvir were 2.473 minutes and 3.316 minutes, respectively. The method showed excellent precision with %RSD values of 0.2 for Sofosbuvir and 0.3 for Velpatasvir. The %recovery was 99.32% for Sofosbuvir and 100.43% for Velpatasvir, indicating accuracy. The limits of detection (LOD) and limits of quantification (LOQ) were found to be 0.44 μg/mL and 1.32 μg/mL for Sofosbuvir, and 0.33 μg/mL and 1.01 μg/mL for Velpatasvir. The regression equations for Sofosbuvir and Velpatasvir were y = 10179x + 3201 and y = 16944x + 13228, respectively. The method reduced retention and run times, making it simple, economical, and suitable for routine quality control in pharmaceutical industries.

Keywords: RP-HPLC Method, Sofosbuvir, Velpatasvir, Method Development.