Quantification of Sofosbuvir in Human Plasma: RP-HPLC Method Development and Validation
- Autores: Rathod R.U.1, Navyasree K.S.1, Bhat K.1
-
Afiliações:
- Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
- Edição: Volume 52, Nº 7 (2018)
- Páginas: 663-673
- Seção: Article
- URL: https://ogarev-online.ru/0091-150X/article/view/245397
- DOI: https://doi.org/10.1007/s11094-018-1878-2
- ID: 245397
Citar
Resumo
Sofosbuvir, a potential inhibitor of the nucleotide analog of hepatitis C virus (HCV) NS5B polymerase, is used to treat hepatitis C and marketed under brand name Sovaldi. This study was aimed to develop and validate a simple, sensitive and precise RP-HPLC method for the estimation of sofosbuvir in human blood plasma using quinine sulfate as internal standard (ISTD). Separation was achieved using Shimadzu-HPLC system equipped with Gracesmart RP-C18 (250 mm × 4.6 mm, 5 μm) column eluted at a flow rate of 0.5 mL/min and detected at 260 nm. The mobile-phase composition was optimized to be ammonium formate (pH 3.0; 10 mM) and acetonitrile (67: 33, % v/v). The retention times of sofosbuvir and quinine sulfate were found to be 13.60 and 8.39 min, respectively. The proposed method was linear over a range from 20 to 1200 ng/mL. Liquid–liquid extraction technique was applied for the extraction of drug and ISTD from human plasma using TBME – DCM (80: 20, % v/v) mixture. The proposed method was validated as per bioanalytical method validation guidelines for industry.
Palavras-chave
Sobre autores
Rahul Rathod
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: km.bhat@manipal.edu
Índia, Madhav Nagar, Manipal, Karnataka, 576104
K. Navyasree
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: km.bhat@manipal.edu
Índia, Madhav Nagar, Manipal, Karnataka, 576104
Krishnamurthy Bhat
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Autor responsável pela correspondência
Email: km.bhat@manipal.edu
Índia, Madhav Nagar, Manipal, Karnataka, 576104
Arquivos suplementares
