Development and validation of analytical method for simultaneous estimation of sofosbuvir and velpatasvir by RP-HPLC method in pharmaceutical dosage form

Abstract

In this work, a simple, rapid, accurate, precise, specific, and sensitive RP-HPLC method was developed and validated for the simultaneous estimation of the Sofosbuvir and Velpatasvir in bulk drug and pharmaceutical dosage form. The stationary phase used for the chromatographic separation was Hypersil BDS column C18 column (250 mm× 4.6 mm with the particle size of 5 mm) andthe mobile phase used for the separation was methanol:phosphate buffer (pH3) taken in ratio of 75:25%V/V. The flow rate was 1.0 mL/min at 30 °C. The drugs were detected at the wavelength of 260 nm. The retention time for the Sofosbuvir (SOFO) and Velpatasvir(VELP) were 3.714 and 5.263, respectively. The linearity was performed using the concentration range of 2-12 µg/mL of Sofosbuvir and 0.5-3 µg/mL of Velpatasvir. The correlation coefficient was found to be 0.999 and 0.999, respectively. The % purity of the Sofosbuvir and Velpatasvir was found to be 99.01% and 99.25%, respectively. The proposed method was validated for specificity, linearity, precision, robustness and accuracy were within the range of acceptance limit according to ICH Q2 (B) guidelines and the developed method can be employed for the routine quality control analysis in the bulk and combined pharmaceutical dosage form of Sofosbuvir and Velpatasvir.