Journal
BIOMEDICAL CHROMATOGRAPHY
Volume 24, Issue 12, Pages 1300-1308Publisher
WILEY
DOI: 10.1002/bmc.1440
Keywords
gemfibrozil; LC/MS; pharmacokinetic; human plasma
Categories
Funding
- National Institutes of Health [K23 DK073197, M01 RR000051]
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Gemfibrozil, a fibric acid hypolipidemic agent, is increasingly being used in clinical drug-drug interaction studies as an inhibitor of drug metabolizing enzymes and drug transporters. The validation of a fast, accurate and precise LC/MS method is described for the quantitative determination of gemfibrozil in an EDTA-anticoagulated human plasma matrix. Briefly, gemfibrozil was extracted from human plasma by an acetonitrile protein precipitation method. The assay was reproducible with intra-assay precision between 1.6 and 10.7%, and inter-assay precision ranging from 4.4 to 7.8%. The assay also showed good accuracy, with intra-assay concentrations within 85.6-108.7% of the expected value, and inter-assay concentrations within 89.4-104.0% of the expected value. The linear concentration range was between 0.5 and 50 mu g/mL with a lower limit of quantitation of 0.5 mu g/mL when 125 mu L of plasma were extracted. This LC/MS method yielded a quick, simple and reliable protocol for determining gemfibrozil concentrations in plasma and is applicable to clinical pharmacokinetic studies. Copyright (C) 2010 John Wiley & Sons, Ltd.
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