title: Hydrophilic interaction chromatography-tandem mass spectrometry of donepezil in human plasma: application to a pharmacokinetic study of donepezil in volunteers.
abstract: A selective, sensitive and rapid hydrophilic interaction liquid chromatography with electrospray ionization tandem mass spectrometry was developed for the determination of donepezil in human plasma. Donepezil was twice extracted from human plasma using methyl tert-butyl ether at basic pH. The analytes were separated on an Atlantis HILIC Silica column with the mobile phase of acetonitrile: ammonium formate (50 mM, pH 4.0) (85:15, v/v) and detected by tandem mass spectrometry in the selective reaction monitoring mode. The calibration curve was linear (r = 0.9994) over the concentration range of 0.10-50.0 ng/mL and the lower limit of quantification was 0.1 ng/mL using 200 muL plasma sample. The coefficient of variation and relative error for intra-and inter-assay at four QC levels were 2.7 to 10.5% and -10.0 to 0.0%, respectively. There was no matrix effect for donepezil and cisapride. The present method was successfully applied to the pharmacokinetic study of donepezil after oral dose of donepezil hydrochloride (10 mg tablet) to male healthy volunteers.
authors.affiliation: Drug Metabolism and Bioanalysis Laboratory, College of Pharmacy, Wonkwang University, Iksan, 570-749, Korea.
authors.forename: Een Jeong
authors.initials: EJ
authors.lastname: Park
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Lee
authors.forename: Hye Young
authors.initials: HY
authors.lastname: Ji
authors.forename: Hoe Yoon
authors.initials: HY
authors.lastname: Kim
authors.forename: Mann Hyung
authors.initials: MH
authors.lastname: Lee
authors.forename: Eun-Seok
authors.initials: ES
authors.lastname: Park
authors.forename: Kang Choon
authors.initials: KC
authors.lastname: Lee
authors.forename: Hye Suk
authors.initials: HS
authors.lastname: Lee
mesh_terms: D000328:Adult; D002138:Calibration; D002853:Chromatography, Liquid; D000077265:Donepezil; D004355:Drug Stability; D005615:Freezing; D006801:Humans; D007189:Indans / Q000097:blood* / Q000493:pharmacokinetics*; D007202:Indicators and Reagents; D008297:Male; D018697:Nootropic Agents / Q000097:blood* / Q000493:pharmacokinetics*; D010880:Piperidines / Q000097:blood* / Q000493:pharmacokinetics*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization; D053719:Tandem Mass Spectrometry
chemical_list: D007189:Indans; D007202:Indicators and Reagents; D018697:Nootropic Agents; D010880:Piperidines; D000077265:Donepezil