Determination of ulixertinib in mice plasma by LC-MS/MS and its application to a pharmacokinetic study in mice

被引：12

作者：

Kumar, Rajinish ^{[1
]}

Suresh, P. S. ^{[1
]}

Rudresh, G. ^{[1
]}

Zainuddin, Mohd ^{[1
]}

Dewang, Purushottam ^{[2
]}

Kethiri, Ragahava Reddy ^{[2
]}

Rajagopal, Sriram ^{[1
]}

Mullangi, Ramesh ^{[1
]}

机构：

[1] Jubilant Biosys Ltd, Ind Suburb, Bangalore 560022, Karnataka, India

[2] Jubilant Biosys Ltd, Ind Suburb, Med Chem, Bangalore 560022, Karnataka, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2016年 / 125卷

关键词：

Ulixertinib; LC-MS/MS; Method validation; Mice plasma; Pharmacokinetics; INHIBITOR BVD-523;

D O I：

10.1016/j.jpba.2016.03.036

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for the quantification of ulixertinib in mice plasma using phenacetin as an internal standard (I.S.) as per regulatory guidelines. Sample preparation was accomplished through a protein precipitation procedure with acetonitrile:methanol mixture. Chromatographic separation was performed on Atlantis dC(18) column using a binary gradient using mobile phase A (0.2% formic acid in water) and B (acetonitrile) at a flow rate of 0.60 mL/min. Elution of ulixertinib and I.S. occurred at similar to 1.07 and 1.20 min, respectively. The total chromatographic run time was 2.5 min. A linear response function was established in the concentration range of 1.58-2054 ng/mL. The intra- and inter-day accuracy and precisions were in the range of 2.11-11.8 and 5.80-11.4%, respectively. This novel method has been applied to a pharmacokinetic study in mice. (C) 2016 Elsevier B.V. All rights reserved.

引用

页码：140 / 144

页数：5

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