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Determination of huperzine A in human plasma by liquid chromatography–electrospray tandem mass spectrometry: application to a bioequivalence study on Chinese volunteers
Author(s) -
Li Wei,
Li Jianhua,
Hu Qin
Publication year - 2008
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.938
Subject(s) - chemistry , chromatography , bioequivalence , huperzine a , electrospray ionization , formic acid , mass spectrometry , tandem mass spectrometry , pseudoephedrine , selected reaction monitoring , pharmacokinetics , liquid chromatography–mass spectrometry , electrospray , ephedrine , pharmacology , medicine , biochemistry , acetylcholinesterase , enzyme
A simple, sensitive and selective LC‐MS‐MS method has been developed for the quantification of huperzine A in human plasma. Huperzine A and pseudoephedrine hydrochloride (internal standard) were isolated from human plasma by extraction with ethyl acetate, chromatographed on a C 18 column with a mobile phase consisting of 0.2% formic acid–methanol (15:85, v/v) and detected using a tandem mass spectrometer with an electrospray ionization interface. The lower limit of quantification was 0.0508 ng/mL, and the assay exhibited a linear range of 0.0508–5.08 ng/mL ( r = 0.9998). The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test vs reference product) in 18 healthy male Chinese volunteers. After a single 0.2 mg dose for the test and reference product, the resulting means of major pharmacokinetic parameters such as AUC 0−24 , AUC 0−∞ , C max , T max and t 1/2 of huperzine A were 16.35 ± 3.42 vs 16.38 ± 3.61 ng h/mL, 17.53 ± 3.80 vs 17.70 ± 3.97 ng h/mL, 2.47 ± 0.49 vs 2.51 ± 0.51 ng/mL, 1.3 ± 0.4 vs 1.2 ± 0.3 h and 5.92 ± 0.75 vs 6.18 ± 0.66 h, respectively, indicating that these two kinds of tablets were bioequivalent. Copyright © 2007 John Wiley & Sons, Ltd.