期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 125, 期 -, 页码 140-144出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2016.03.036
关键词
Ulixertinib; LC-MS/MS; Method validation; Mice plasma; Pharmacokinetics
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.
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