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Determination and pharmacokinetic study of Enasidenib in rat plasma by UPLC–MS/MS

机译:UPLC-MS / MS在大鼠等离子体中enaSidenib的测定和药代动力学研究

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摘要

Enasidenib, an oral product for treating Acute Myeloid Leukemia, has been approved by FDA in Aug, 2017. In this study, we set up an ultra-performance liquid chromatography-mass spectrometry (UPLC-MS/MS) method for measuring Enasidenib and imatinib (internal standard, IS), simultaneously. Enasidenib and imatinib were separated on an ACQUITY UPLC BEH C18Column (2.1?mm?×?50?mm, 1.7?μm, 132??). Mass detection was carried out by electrospray ionization in the position mode, and the multiple reaction monitoring transitions werem/z?474.23?→?456.17 andm/z?494.30?→?394.20 for Enasidenib and imatinib, respectively. Linearity (2???500?ng·mL?1, R2?>?0.999), precision and accuracy (RE?
机译:Enasidenib是一种治疗急性髓性白血病的口服产品,已于2017年8月获得FDA批准。在本研究中,我们建立了用于测量Enasidenib和伊马替尼的超高效液相色谱 - 质谱(UPLC-MS / MS)方法(内标,是)同时。在Acquity UPLC BEB C18Column上分离Enasidenib和iMatinib(2.1?mm?×50?mm,1.7?μm,132)。通过电喷雾电离在位置模式下进行质谱,以及多次反应监测转换,→474.23?→456.17和Z?494.30分别用于enasidenib和imatinib的→394.20。线性度(2 ??? 500?ng·ml?1,R2?>?0.999),精度和精度(RE?<?±15%),提取恢复(≥96.69%),基质效果(≥?96.47验证%)和稳定性(RE?<?±10%),其证明了我们方法的稳健性。这种快速,高效可靠的UPLC-MS / MS方法显示了大鼠等离子体中Enasidenib的特异性和可重复性,可用于进一步的药代动力学研究。

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