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 study

Journal of Pharmaceutical and Biomedical Analysis - Tập 114 - Trang 97-104 - 2015
Mamdouh R. Rezk1, Emad B. Basalious2, Iman A. Karim3
1Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt
2Pharmaceutics and Industrial Pharmacy Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt
3Advanced Research Center (ARC), Nasr City, Cairo, Egypt

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Sofia, 2010, Discovery of a beta-d-2′-deoxy-2′-alpha-fluoro-2′-beta-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus, J. Med. Chem., 53, 7202, 10.1021/jm100863x

Eldrup, 2004, Structure-activity relationship of heterobase-modified 2′-C-methyl ribonucleosides as inhibitors of hepatitis C virus RNA replication, J. Med. Chem., 47, 5284, 10.1021/jm040068f

Berden, 2014, Dutch guidance for the treatment of chronic hepatitis C virus infection in a new therapeutic era, Neth. J. Med., 72, 388

Cholongitas, 2014, Sofosbuvir: a novel oral agent for chronic hepatitis C, Ann. Gastroenterol., 27, 331

Cha, 2014, Sofosbuvir: a new oral once-daily agent for the treatment of hepatitis C virus infection, Pharm. Ther., 39, 345

FDA, Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CV) (2001).

Zimmer, 2014, New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR, Bioanal., 6, 13, 10.4155/bio.13.298

Dams, 2003, Matrix effect in bio-analysis of illicit drugs with LC-MS/MS: influence of ionization type, sample preparation, and biofluid, J. Am. Soc. Mass Spectrom., 14, 1290, 10.1016/S1044-0305(03)00574-9

Van Eeckhaut, 2009, Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 2198, 10.1016/j.jchromb.2009.01.003

De Nardi, 2006, Moving from fast to ballistic gradient in liquid chromatography/tandem mass spectrometry pharmaceutical bioanalysis: matrix effect and chromatographic evaluations, Rapid Commun. Mass Spectrom., 20, 2709, 10.1002/rcm.2649

Sauvage, 2006, A fully automated turbulent-flow liquid chromatography-tandem mass spectrometry technique for monitoring antidepressants in human serum, Ther. Drug Monit., 28, 123, 10.1097/01.ftd.0000194026.04483.c3

Alberti, 2014, The evolution of the therapeutic strategy in hepatitis C: features of sofosbuvir and indications, Dig. Liver Dis., 46, S174, 10.1016/j.dld.2014.09.028

Sathe, 1999, Evaluation of truncated areas in the assessment of bioequivalence of immediate release formulations of drugs with long half-lives and of Cmax with different dissolution rates, Pharm. Res., 16, 939, 10.1023/A:1018898624643

Rezk, 2014, Development, optimization and validation of a highly sensitive UPLC-ESI-MS/MS method for simultaneous quantification of amlodipine, benazeprile and benazeprilat in human plasma: application to a bioequivalence study, J. Pharm. Biomed. Anal., 98, 1, 10.1016/j.jpba.2014.05.005