Transl Clin Pharmacol.  2018 Jun;26(2):64-72. 10.12793/tcp.2018.26.2.64.

Determination of donepezil in human plasma using ultra performance liquid chromatography-tandem mass spectrometry

  • 1College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu 41566, Korea.
  • 2Dong-A University Hospital, Busan 49201, Korea.
  • 3Clinical Trials Center, Gachon University Gil Medical Center, Incheon 21565, Korea.


An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the quantification of donepezil in human plasma. Donepezil and donepezil-D4 were extracted from human plasma by liquid-liquid extraction using a mixture of hexane and ethyl acetate (70:30 v/v). The extracted samples were analyzed using a Thermo Hypersil Gold C18 column with 5% acetic acid in 20 mM ammonium acetate buffer (pH 3.3) and 100% acetonitrile as a mobile phase with the 60:40 (v:v) isocratic method, at a flow rate of 0.3 mL/min. The injection volume was 3 µL, and the total run time was 3 min. Inter- and intra-batch accuracies ranged from 98.0% to 110.0%, and the precision was below 8%. The developed method was successfully applied to the quantification of donepezil in human plasma. The mean (standard deviation) maximum concentration and the median (range) time to maximum concentration were 8.6 (2.0) ng/mL and 2.0 h (1.0~5.0 h), respectively, in healthy Koreans after oral administration of 5 mg donepezil.


Acetylcholinesterase inhibitor; Donepezil; Human plasma; Method validation; UPLC-MS/MS
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