Forced Oxidative Degradation of Anti-Hepatitis C Drugs Sofosbuvir and Daclatasvir: Characterization and Quantification

Abstract

This study focuses on the analysis of hepatitis C drugs, specifically sofosbuvir (SOF) and daclatasvir (DCL), and their oxidative products. The drugs were isolated and characterized using FTIR, 1HNMR, and Mass Spectrometry techniques. Additionally, the drugs were oxidized using cerium (IV) in the presence of sulfuric acid at 100ºC. A spectrophotometric method was developed for the quantitative analysis of SOF and DCL in pure and pharmaceutical forms. The oxidation of the drugs was monitored by back determination of residual Ce(IV) using Fe(II) with ferroin as an indicator at 510 nm. The method demonstrated good sensitivity with RSD%<1.0, and the data were statistically analyzed using t- and F-tests.