title: Validation of an LC/MS method for the determination of gemfibrozil in human plasma and its application to a pharmacokinetic study.
abstract: 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 µg/mL with a lower limit of quantitation of 0.5 µg/mL when 125 µL 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.
authors.affiliation: University of Colorado Denver, School of Pharmacy, Department of Pharmaceutical Sciences, Aurora, Colorado, USA.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Rower
authors.forename: Lane R
authors.initials: LR
authors.lastname: Bushman
authors.forename: Kyle P
authors.initials: KP
authors.lastname: Hammond
authors.forename: Rajendra S
authors.initials: RS
authors.lastname: Kadam
authors.forename: Christina L
authors.initials: CL
authors.lastname: Aquilante
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D015248:Gemfibrozil / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D000960:Hypolipidemic Agents / Q000097:blood*; D013058:Mass Spectrometry / Q000379:methods*
chemical_list: D000960:Hypolipidemic Agents; D015248:Gemfibrozil