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Determination of the novel antiarrhythmic drug sulcardine sulfate in human plasma by liquid chromatography tandem mass spectrometry and its application in a clinical pharmacokinetic study
Author(s) -
Jia Jingying,
Liu Gangyi,
Zhang Mengqi,
Lu Youli,
Lu Chuan,
Liu Yun,
Zheng Hongcao,
Wang Wei,
Gui Yuzhou,
Yu Chen,
Li Shuijun,
Wang Yiping
Publication year - 2016
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.3681
Subject(s) - chemistry , chromatography , pharmacokinetics , formic acid , tandem mass spectrometry , liquid chromatography–mass spectrometry , mass spectrometry , selected reaction monitoring , acetonitrile , pharmacology , medicine
Sulcardine sulfate (Sul), a novel antiarrhythmic agent, is currently in phase I and phase II clinical trials. To elucidate its clinical pharmacokinetic characteristics, a rapid and accurate liquid chromatography–tandem mass spectrometry (LC–MS/MS) method has been developed and validated for the quantification of Sul in human plasma. Plasma samples were precipitated by acetonitrile and isotope‐labeled sulcardine was added as internal standard. The analysis was carried out on a Capcell Pak C 18 MG III column (100 × 2.0 mm, 5 μm) with 0.1% formic acid in acetonitrile solution and water (17:83, v /v) as mobile phase. The linear range was 5.0–1000 ng/mL for Sul, with a lower limit of quantification of 5.0 ng/mL. The intra‐ and inter‐batch CVs were within ±11.0% and the accuracies were 4.9–107.3%. Our method, for the first time, allows the rapid (only 3.0 min) and accurate quantification of Sul in human plasma. The method has been successfully applied in the pharmacokinetic study of Sul in a clinical trial following oral administration of Sul to healthy volunteers. Copyright © 2016 John Wiley & Sons, Ltd.