Hydrophilic interaction chromatography-tandem mass spectrometry of donepezil in human plasma: application to a pharmacokinetic study of donepezil in volunteers.
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.
Park
Een Jeong
EJ
Drug Metabolism and Bioanalysis Laboratory, College of Pharmacy, Wonkwang University, Iksan, 570-749, Korea.
Lee
Hye Won
HW
Ji
Hye Young
HY
Kim
Hoe Yoon
HY
Lee
Mann Hyung
MH
Park
Eun-Seok
ES
Lee
Kang Choon
KC
Lee
Hye Suk
HS
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
D007189:Indans; D007202:Indicators and Reagents; D018697:Nootropic Agents; D010880:Piperidines; D000077265:Donepezil