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

Authors : Nastaran Heıdarzadeh Khoramabadı, Nasrın Nemayandeh, Ali Mohammadi, Roderick B Walker

Pages : 187-210

Doi:10.55262/fabadeczacilik.1416240

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Publication Date : 2025-03-25

Article Type : Review Paper

Abstract :Sofosbuvir (SOF) is an antiviral compound used alone for the treatment of 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 been reported the analysis of SOF in bulk and tablet forms. However, a monograph for SOF has not yet been included in official pharmacopoeias. Therefore, no consensus in respect of identification of impurities and concerns relating to safety of the drug exists. A review of the development of stability indicating chromatographic methods for 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 in tablet form alone and in combination with LED, daclatasvir (DAC), velpatasvir (VEL) and voxilaprevir (VOX) and also reported the use of stress testing. The purpose of this review is to summarize the information reported in different studies in respect of the development of stability indicating methods conducted using stress studies for the analysis of SOF and the results of such stress studies.
Keywords : Sofosbuvir, anti-virus drug, stability indicating, method development, stress studies