Forced Degradation and Stability Indicating Chromatographic Methods for the Analysis of Sofosbuvir Alone and in Combination With Velpatasvir, Daclatasvir, Voxilaprevir and Ledipasvir Publisher



Heidarzadeh Khoramabadi N¹ ; Nemayandeh N¹ ; Mohammadi A² ; Walker RB³ Show Affiliations
Source: Fabad Journal of Pharmaceutical Sciences Published:2025

Abstract

Sofosbuvir (SOF) is an antiviral compound used alone to treat hepatitis C or in combination with drugs such as ribavirin and ledipasvir (LED). FDA approval as monotherapy was granted in 2013, and for combination treatment of hepatitis C in 2014. Different studies have reported on the analysis of SOF in bulk and tablet forms. However, a monograph for SOF has not yet been included in official pharmacopeias. Therefore, no consensus with respect to the identification of impurities and concerns relating to the safety of the drug exists. A review of the development of stability indicating chromatographic methods for the analysis of SOF was undertaken using PubMed and the Google Scholar databases from initial reports to January 2023. Our focus pertained to studies in which a stability-indicating chromatographic method had been designed and validated for analysis of SOF in bulk and tablet form alone and in combination with LED, daclatasvir (DAC), velpatasvir (VEL) and voxilaprevir (VOX) and also reported the use of stress testing. This review aims to summarize the information reported in different studies concerning the development of stability-indicating methods conducted using stress studies to analyze SOF and the results of such stress studies. © 2025 Society of Pharmaceutical Sciences of Ankara (FABAD). All rights reserved.