Stability indicating RP-HPLC method development and validation for the estimation of sofosbuvir, velpatasvir and voxilaprevir in bulk and pharmaceutical dosage form

A simple, accurate, precise RP-HPLC method was developed for the simultaneous estimation of the Sofosbuvir, Velpatasvir and Voxilaprevir Tablet [Vosevi®] dosage form. The method was carried through Agilent C18 150 × 4.6mm, 5m, with mobile phase containing buffer 0.01N Na₂HPO₄ and acetonitrile in the ratio of 60:40, pumped through column at 1ml/min flow rate, pH was adjusted to 4.5 with dilute orthophosphoric acid solution at 220 nm wavelength. Retention time of Sofosbuvir, Velpatasvir and Voxilaprevir were 2.229 min, 2.957 min and 3.568 min respectively. The proposed triple combination method can be used for estimation of these drugs in combined dosage forms. All the validation study was found statistically significant because all the statistical parameters were within the acceptance range for both accuracy and precision. The %RSD of Sofosbuvir, Velpatasvir and Voxilaprevir were observed as 0.8, 1.0 and 0.7 respectively. The % recovery was obtained as 100. 27%, 100.78% and 100.10% for Sofosbuvir, Velpatasvir and Voxilaprevir respectively. The high recovery and low coefficient of variation % revealed the reliability of the method for quantitative study of three drugs in Vosevi® tablets. The method is a rapid and cost-effective quality-control tool for routine quantitative analysis of Sofosbuvir, Velpatasvir and Voxilaprevir in tablet dosage form.