Development and Validation of a New Stability Indicating RP-UFLC Method for the Simultaneous Estimation of Velpatasvir and Sofosbuvir in Pharmaceutical Formulations

Velpatasvir is a directly acting anti-viral medication used for the inhibition of hepatitis C virus. Sofosbuvir is a directly acting anti-viral medication used for the treatment of chronic hepatitis C virus infection. The combination of Sofosbuvir and Velpatasvir works by stopping the hepatitis C virus from spreading inside the body. A new liquid chromatographic method has been developed for the simultaneous determination of Sofosbuvir and Velpatasvir in oral dosage forms. Shimadzu Model CBM-20A/20 Alite UFLC system with PDA detector and Zorbox C₁₈ column were used for the chromatographic study. Mobile phase mixture consisting of 0.1% Acetic acid: Acetonitrile (35:65) with a flow rate 1.0ml/min was chosen for the simultaneous determination of Sofosbuvir and Velpatasvir (Detection wavelength 260nm). Linearity was observed over the concentration range 4.0-400μg/ml and 1.0-100μg/ml with regression equations y = 30222x + 1253.9 (R² = 0.9999) and y = 38962x +292.37 (R² = 0.9999) for Sofosbuvir and Velpatasvir respectively. The combination of Sofosbuvir and Velpatasvir was subjected to forced degradation conditions and the method was validated as per ICH guidelines.