RP-HPLC Method for Simultaneous Quantification and Validation of Sofosbuvir and Velpatasvir in Bulk Drugs and Formulations

Abstract

Pharmaceutical analysis is crucial for both quality assurance and quality control of
bulk drugs and pharmaceutical formulations. Analytical method development has become a
fundamental activity in pharmaceutical analysis by using advanced analytical techniques like
GC, HPLC, IC, LCMS, GCMS etc. Analytical techniques are developed and validated for a
range of substances including active pharmaceutical ingredients (APIs), excipients, drug
products, degradation products, related substances and residual solvents. These validated
methods have become essential requirements for regulatory organizations. Regulatory
authorities are increasingly emphasizing the importance of robust analytical methods in the
manufacturing process. To gain drug approval, applicants must demonstrate comprehensive
control over the drug development process using validated analytical methods. I. Introduction
Sofosbuvir and Velpatasvir combination is used in the treatment of chronic hepatitis C virus
(HCV) infection.