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Quantitation of bivalirudin,a novel anticoagulant peptide,in human plasma by LC-MS/MS:Method development,validation and application to pharmacokinetics

查看全文 作　　者：Xiao-Jiao [1,2]Li;Yan-Tong [1,2]Sun;Lei [1]Yin;Xue-Ju [2]Zhang;Yan [1,2]Yang;J.Paul [3]Fawcett;Yi-Min [4]Cui;Jing-Kai [1,2]Gu 高影响力作者 机构地区：[1]Clinical Pharmacology Center,Research Institute of Translational Medicine,The First Bethune Hospital of Jilin University;[2]Research Center for Drug Metabolism,College of Life Science,Jilin University;[3]School of Pharmacy,University of Otago;[4]Department of Pharmacy,Peking University First Hospital高影响力机构 出　　处：《Journal of Pharmaceutical Analysis》索引2013年第3卷第1期,共8页高影响力期刊 基　　金：the National Natural Science Foundation (30973587);the China Postdoctoral Science Foundation (20110491328);the National Natural Science Funds for Young Scholar (81102383)for financial support 摘　　要：A rapid and sensitive method based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and re-extracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-C18 column (150 mm 4.6 mm i.d., 5 mm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiple-reaction monitoring (MRM) transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5-249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 mL plasma sample and the assay was linear over the concentration range 1-1000 ng/mL. The accuracy was within a range from 0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were r2.92 and r3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. 关 键 词：药代动力学 人体血浆 抗凝血剂 开发 应用 验证 S方法 LC-MS MS
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