New RP-HPLC Method for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Combined Pharmaceutical Dosage Forms

Abstract

For simultaneous estimation of SOF & VEL in bulk and pharmaceutical dosage form, a quick, rapid, reliable, precise and sensitive RP-HPLC method has been developed and validated. On Discovery C18 (4.6 x250 mm, 5 μm), the chromatographic separation was achieved using a mobile phase buffer (60 %; 0.01 N KH2PO4: 40 % acetonitrile, 1.0 ml/min fluid at a room temperature, detection at 260 nm). SOF & VEL had retention periods of 2.373 and 2.967 min. Linearity for both of drugs was conducted at a concentration range of 100-600 μg / mL, 25-150 ppm, and the correlation range was 0.999 and 0.999 respectively in SOF & VEL. SOF & VEL have respectively been shown to be pure at a rate of 99.30 and 99.83 %. The proposed method is validated for the specificities, lines, range, precision and robustness of SOF & VEL in bulk and the combined pharmaceutical dosage form according to the guidelines of ICH Q2 (B) and can be employed for the routine quality test.