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

详细信息    查看全文

• 作者：Jingying Jia ; Gangyi Liu ; Mengqi Zhang ; Youli Lu ; Chuan Lu ; Yun Liu ; Hongcao Zheng ; Wei Wang ; Yuzhou Gui ; Chen Yu ; Shuijun Li and Yiping Wang
• 刊名：Biomedical Chromatography
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：30
• 期：8
• 页码：1291-1296
• 全文大小：362K
• ISSN：1099-0801

文摘

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