School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.
School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.
J Pharm Biomed Anal. 2018 Aug 5;157:165-170. doi: 10.1016/j.jpba.2018.04.039. Epub 2018 Apr 27.
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 C Column (2.1 mm × 50 mm, 1.7 μm, 132 Å). Mass detection was carried out by electrospray ionization in the position mode, and the multiple reaction monitoring transitions were m/z 474.23 → 456.17 and m/z 494.30 → 394.20 for Enasidenib and imatinib, respectively. Linearity (2 - 500 ng·mL, R > 0.999), precision and accuracy (RE < ± 15%), extraction recovery (≥ 96.69%), matrix effect (≥ 96.47%) and stability (RE < ± 10%) were validated which demonstrated the robustness of our method. This rapid, efficient and reliable UPLC-MS/MS method shows specificity and repeatability of Enasidenib in rat plasma and can be used in further pharmacokinetic studies.
依尼西尼布，一种用于治疗急性髓性白血病的口服药物，于 2017 年 8 月获得 FDA 批准。在这项研究中，我们建立了一种超高效液相色谱-质谱法（UPLC-MS/MS），同时测定依尼西尼布和伊马替尼（内标，IS）。依尼西尼布和伊马替尼在 ACQUITY UPLC BEH C 柱（2.1mm×50mm，1.7μm，132Å）上分离。采用电喷雾电离位置模式进行质谱检测，依尼西尼布和伊马替尼的多反应监测转换分别为 m/z 474.23→456.17 和 m/z 494.30→394.20。该方法的线性范围为 2-500ng·mL，R>0.999，精密度和准确度（RE<±15%），提取回收率（≥96.69%），基质效应（≥96.47%）和稳定性（RE<±10%）均得到验证，表明该方法具有良好的稳定性。该快速、高效、可靠的 UPLC-MS/MS 方法显示了大鼠血浆中依尼西尼布的特异性和重现性，可用于进一步的药代动力学研究。
