Method Development and Validation for the Simultaneous estimation of Velpatasvir and Sofosbuvir in tablet dosage form by using RP–HPLC

M. Anusha*, B.V. Ramana, G. Nagarajan
Dr. K.V. Subba Reddy Institute of Pharmacy, Kunrool, Andhra Pradesh, India

A B S T R A C T
The present research work mainly focused on method development and validation for the simultaneous estimation of velpatasvir and sofosbuvir in tablet dosage form by using RP-HPLC. Chromatographic separation was carried on YMC C₁₈ column (4.6*150mm, 5µ) and it maintained flow rate was 1.0 ml/min. The mobile phase consist of phosphate buffer pH 3.0 was adjusted with ortho phosphoric acid and acetonitrile with the ratio of 50:50%v/v, then UV spectrum was monitored at 255 nm. The retention time was found to be 3.472 min for velpatasvir and 5.505 min for sofosbuvir. The method shows linear response in the range of concentration was 50-250µg/ml for velpatasvir and 200-1000 µg/ml for sofosbuvir respectively. The developed method was stastically validated according to ICH guidelines. The validation parameters are present within the limit. So, the developed method was simple, precise, accurate and robust. It can be suggested that routine quality control analysis of analytical laboratories.
Keywords: Velpatasvir, Sofosbuvir, Mobile phase, Validation, ICH guidelines