Bioequivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method
Open Access
- 30 April 2013
- journal article
- research article
- Published by Springer Science and Business Media LLC in SpringerPlus
- Vol. 2 (1), 194
- https://doi.org/10.1186/2193-1801-2-194
Abstract
A bioequivalence study was proved of generic Febuxostat 80 mg tablets (T) in healthy volunteers.For this purpose, Authors developed a simple, sensitive, selective, rapid, rugged and reproducible liquid chromatography–tandem mass spectrometry method for the quantification of Febuxostat (FB) in human plasma using Febuxostat D7 (FBD7) as an internal standard (IS) was used. Chromatographic separation was performed on Ascentis Express C18 (50x4.6 mm, 3.5 μ) column. Mobile phase composed of 10 mM Ammonium formate: Acetonitrile (20:80 v/v), with 0.8 mL/min flow-rate. Drug and IS were extracted by Liquid- liquid extraction. FB and FBD7 were detected with proton adducts at m/z 317.1→261.1 and 324.2→262.1 in multiple reaction monitoring (MRM) positive mode respectively. The method was validated with the correlation coefficients of (r2) ≥ 0.9850 over a linear concentration range of 1.00-8000.00 ng/mL. This method demonstrated intra and inter-day precision within 2.64 to 3.88 and 2.76 to 8.44% and accuracy within 97.33 to 99.05 and 100.30 to 103.19% for FB. This method is successfully applied in the Bioequivalence study of 9 human volunteers.Keywords
This publication has 15 references indexed in Scilit:
- Febuxostat for treating chronic goutEmergencias, 2012
- Establishment of inherent stability of febuxostat and development of a validated stability-indicating method by UPLC according to ICH requirementMedicinal Chemistry Research, 2012
- Ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of febuxostat in dog plasma and its application to a pharmacokinetic studyBiomedical Chromatography, 2012
- Development and validation of a liquid chromatography–tandem mass spectrometry method for the determination of febuxostat in human plasmaBiomedical Chromatography, 2012
- Study of impurity carryover and impurity profile in Febuxostat drug substance by LC–MS/MS techniqueJournal of Pharmaceutical and Biomedical Analysis, 2011
- Multicenter, Open-Label Study of Long-Term Administration of Febuxostat (TMX-67) in Japanese Patients With Hyperuricemia Including GoutJCR: Journal of Clinical Rheumatology, 2011
- 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid pyridine solvateActa Crystallographica Section E Structure Reports Online, 2009
- Effect of food or antacid on pharmacokinetics and pharmacodynamics of febuxostat in healthy subjectsBritish Journal of Clinical Pharmacology, 2007
- Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: A twenty‐eight–day, multicenter, phase II, randomized, double‐blind, placebo‐controlled, dose‐response clinical trial examining safety and efficacy in patients with goutArthritis & Rheumatism, 2005
- Determination of Plasma Purine Nucleoside Phosphorylase Activity by High-Performance Liquid ChromatographyAnalytical Biochemistry, 1995