title: 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.
abstract: 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 C18 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.
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Jingying
authors.initials: J
authors.lastname: Jia
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Gangyi
authors.initials: G
authors.lastname: Liu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Mengqi
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Youli
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Chuan
authors.initials: C
authors.lastname: Lu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Hongcao
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Department of Cardiology, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zuchongzhi Road, Shanghai, 201203, China.
authors.forename: Yuzhou
authors.initials: Y
authors.lastname: Gui
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Yu
authors.affiliation: Central Laboratory, Shanghai Xuhui Central Hospital and Shanghai Clinical Center, Chinese Academy of Science, 966 Middle Huaihai Road, Shanghai, 200031, China.
authors.forename: Shuijun
authors.initials: S
authors.lastname: Li
authors.affiliation: State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zuchongzhi Road, Shanghai, 201203, China.
authors.forename: Yiping
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000097:blood* / Q000493:pharmacokinetics; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D015203:Reproducibility of Results; D013463:Sulfuric Acid Esters / Q000097:blood* / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000889:Anti-Arrhythmia Agents; D013463:Sulfuric Acid Esters; C558473:sulcardine sulfate
keywords: anti-arrhythmic agent; bioanalytical method; liquid chromatography-tandem mass spectrometry; pharmacokinetics; sulcardine sulfate