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

被引：13

作者：

Pang, Ni-hong ^{[1
]}

Liu, Qian ^{[1
]}

Lu, Xiang-ran ^{[1
]}

Yang, Su-fen ^{[1
]}

Lin, Dong-dong ^{[1
]}

Hu, Guo-xin ^{[1
]}

机构：

[1] Wenzhou Med Univ, Sch Pharmaceut Sci, Wenzhou 325035, Zhejiang, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2018年 / 157卷

关键词：

Enasidenib; UPLC-MS/MS; Rat plasma; Pharmacokinetic study; ACUTE MYELOID-LEUKEMIA; IDH2; MUTATIONS; OPEN-LABEL; PHASE-III; 2-HYDROXYGLUTARATE; DIFFERENTIATION; CELLS; CARE;

D O I：

10.1016/j.jpba.2018.04.039

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

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 C-18 Column (2.1 mm x 50 mm, 1.7 mu m, 132 angstrom). 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(-1), R-2 > 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. (C) 2018 Elsevier B.V. All rights reserved.

引用

页码：165 / 170

页数：6

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