A novel stability indicating method development and validation for the simultaneous estimation of Velpatasvir & Sofosbuvir in bulk and its pharmaceutical formulations

Abstract

A simple and rapid RP–HPLC method, for the simultaneous determination of Velpatasvir and Sofosbuvir, was developed in bulk and its tablet dosage form. Separation was performed on a Water’s C18 4.6 mm × 15 cm, five μm particle column at ambient temperature. The mobile phase consisted of Sodium dihydrogen orthophosphate buffer (pH 4.2, adjusted with OPA) and ACN in the ratio of 85:15 v/v at a flow rate of 1ml/min. Both the analytes were determined using a photodiode array at 292 nm. The retention time of Velpatasvir and Sofosbuvir was found to be 2.89 and 3.84 min, respectively. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linear dynamic ranges were from 32.5 – 97.5 µg/ml and 125 – 375 µg/ml for Velpatasvir and Sofosbuvir, respectively. The percentage recovery obtained for Velpatasvir and Sofosbuvir was 99.53 and 100.26%, respectively. Limit of detection and quantification for Velpatasvir were 0.0068 and 0.029 µg/ml, for Sofosbuvir 0.104 and 0.347 µg/ml, respectively. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation.