Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR CONCURRENT ASSESSMENT BY RP-HPLC OF SOFOSBUVIR AND VELPATASVIR IN PHARMACEUTICAL DOSAGE FORM

Atif Ali*, Sayed Muzahir Hussain, Awais Shabir, Muhammad Zubair Khan, Tanseer Abbas, Muhammad Jamil and Mugheer Pervaiz

Abstract

Purpose: The major purpose of this research is the development of a novel, simple, precise, fast and cheap RP HPLC method for quantifying Velpatasvir and Sofosbuvir in tablet formulation. Methods: The separation of these molecules was performed on C18 column (250 x 4.6 mm, 5 μm) of PHENOMENEX. The above process was executed with the help of a mobile phase that contain mixture of phosphate buffer of 0.02 M (pH 5.0) and acetonitrile in a ratio of 450:550 by inducing a 20 μl sample. The wavelength was selected to be 280 nm with 01 ml / min flow rate. Results: Velpatasvir and Sofosbuvir retention time values were 8.8 and 3.3 min, and the linearity range was 96-144 μg / ml for Sofosbuvir and 24-36 μg / ml for Velpatasvir respectively. Correlation coefficient of Velpatasvir is 0.9996 and 0.9998 was of Sofosbuvir. Conclusion: The method validates specificity, accuracy, precision, linearity, robustness, LOD and LOQ.

Keywords: Velpatasvir, Sofosbuvir, RP-HPLC.