Abstract
STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN DRUG PRODUCT

A. Vimala Devi* and K. Nithyanand Reddy

ABSTRACT

The new Analytical method was developed for the estimation of Sofosbuvir and Velpatasvir in drug product by RP-HPLC. The chromatographic separation was achieved by ECLIPSE XDB Phenyl Column 250 mm*4.6,5um at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid :Acetonitrile: Methanol(30:40:30) The flow rate was 1.2ml/ minute and UV-detection was at 267nm. The average retention time for Sofosbuvir and Velpatasvir was found to be 2.671 min and 3.425 min. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 40-120μg/ml for Sofosbuvir and 10-30μg/ml of Velpatasvir.

Keywords: Sofosbuvir and Velpatasvir, HPLC, Eclipse XDB phenyl Formic acid, Acetonitrile, Methanol, and validation.


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