色谱法
人血浆
药代动力学
代谢物
等离子体
化学
药理学
医学
物理
生物化学
量子力学
作者
Shaoyuan Wang,Xin Zheng,Yanbao Zhang,Pei Hu,Lieming Ding,Li Mao,Ji Jiang
出处
期刊:Bioanalysis
[Newlands Press Ltd]
日期:2019-04-01
卷期号:11 (8): 773-784
标识
DOI:10.4155/bio-2018-0307
摘要
Aim: BPI15086 is a potent, irreversible mutant-selective inhibitor of both EGFR (EGFR tyrosine kinase inhibitor) and the T790M resistance mutations tyrosine kinase. A simultaneous quantification method of BPI15086 and its main metabolite in human plasma using LC-MS/MS is documented and fully validated in this study. Methodology & results: Plasma samples were extracted and chromatographed on an Acquity ultra-high performance liquid chromatography BEH C18 column with a gradient elution. Detection was performed on a Sciex 5500 QTRAP® mass spectrometer using positive electrospray ionization. The results indicated that the method had excellent sensitivity and specificity. Conclusion: For the first time a sensitive and robust ultra-high performance liquid chromatography-MS/MS method was established and validated of BPI15086 in human plasma, this method was successfully applied in a first-in-human Phase I clinical trial studying the pharmacokinetics of the BPI15086 tablet in Chinese non-small-cell lung cancer patients.
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