Abstract

A simple, rapid, accurate, precise and economical reverse phase Ultra performance liquid chromatographic method was developed for simultaneous quantification of two anti-viral drugs, viz., Sofosbuvir and Velpatasvir. The separation of both the drugs was achieved on Endeavorsil C 18 column (2.1 × 50 mm, 2.5 μm particle size) as a mobile phase with phosphate buffer (at pH 3): Acetonitrile (50:50 v/v). The flow rate was 0.3 ml/min and detection was done at 240 nm based on isobestic point. The retention time of Sofosbuvir and for Velpatasvir was 2.7 mins and 1.7 mins respectively. The proposed method was validated as per ICH guidelines. The linearity of the method was evaluated at a range of 10 to 50μg/ml and 40 to 200μg/ml for sofosbuvir and Velpatasvir respectively. The Correlation Coefficient of Sofosbuvir and Velpatasvir were 0.999 each. Precision studies were carried out and % RSD of peak areas of Sofosbuvir and Velpatasvir was about 0.6 and 1.6 respectively. The percentage recoveries of both the drugs Sofosbuvir and Velpatasvir from the tablet formulation were 99.79% and 99.95% respectively. Results obtained for LOQ, LOD and Robustness were well within the acceptance criteria. Validation results indicated that the method is linear, accurate, precise, and robust. The simple mobile phase composition makes this method cost effective, rapid, and non-tedious and can also be successfully adopted for simultaneous estimation of both drugs in commercial products.

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