Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms
Open Access
- 30 September 2016
- journal article
- Published by European Journal of Chemistry in European Journal of Chemistry
- Vol. 7 (3), 375-379
- https://doi.org/10.5155/eurjchem.7.3.375-379.1439
Abstract
Two methods, a reversed phase high-performance liquid chromatographic (RP-HPLC) method and a direct ultra-violet spectrophotometric method, were adopted and validated for the quantification of sofosbuvir, which is a new antiviral agent used for treatment of patients with hepatitis C virus (HCV). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification were determined according to the guidelines of International Conference on Harmonization (ICH)-Q2B. The RP-HPLC method was applied on HypersilTM ODS C18 column (150×4.6 mm, 5 µm) as a stationary phase. The mobile phase was optimized according to the polarity of the studied drug. It was methanol: acetonitrile (90:10, v:v), pumped using an isocratic mode with flow rate of 1 mL/min and UV detection at 260 nm. The UV spectrophotometric method was performed for the studied drug at 260 nm. The calibration curves were linear in the ranges of 2-60 µg/mL and 5-40 µg/mL for the RP-HPLC and UV spectrophotometric methods, respectively. The proposed methods are accurate, sensitive and precise, so they can be successfully adopted for the reliable determination of sofosbuvir content in its tablet form.Keywords
This publication has 8 references indexed in Scilit:
- Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic studyJournal of Chromatography B, 2016
- Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MSJournal of Chromatography B, 2015
- Development of a sensitive UPLC-ESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: Application to a bioequivalence studyJournal of Pharmaceutical and Biomedical Analysis, 2015
- Sofosbuvir for the treatment of hepatitis C virusExpert Opinion on Pharmacotherapy, 2013
- Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infectionExpert Opinion on Investigational Drugs, 2013
- Nucleotide Polymerase Inhibitor Sofosbuvir plus Ribavirin for Hepatitis CThe New England Journal of Medicine, 2013
- Development and validation of RP-HPLC and ultraviolet spectrophotometric methods of analysis for the quantitative estimation of antiretroviral drugs in pharmaceutical dosage formsJournal of Chromatography B, 2006
- Simultaneous determination of digoxin and permeability markers in rat in situ intestinal perfusion samples by RP-HPLCJournal of Chromatography B, 2004