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Open AccessArticle

An Accurate and Effective Method for Measuring Osimertinib by UPLC-TOF-MS and Its Pharmacokinetic Study in Rats

1
National Clinical Drug Monitoring Center, Department of Pharmacy, Hebei Province General Center, Shijiazhuang 050051, China
2
Department of Pharmaceutics, School of Pharmacy, China Medical University, Shenyang 110001, China
3
Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
*
Authors to whom correspondence should be addressed.
Academic Editor: In-Soo Yoon
Molecules 2018, 23(11), 2894; https://doi.org/10.3390/molecules23112894
Received: 15 October 2018 / Revised: 29 October 2018 / Accepted: 3 November 2018 / Published: 6 November 2018
(This article belongs to the Special Issue Method Development and Validation in Food and Pharmaceutical Analysis)
Osimertinib, a new-generation inhibitor of the epidermal growth factor, has been used for the clinical treatment of advanced T790M mutation-positive tumors. In this research, an original analysis method was established for the quantification of osimertinib by ultra-performance liquid chromatography with time of flight mass spectrometry (UPLC-TOF-MS) in rat plasma. After protein precipitation with acetonitrile and sorafinib (internal standard, IS), they were chromatographed through a Waters XTerra MS C18 column. The mobile phase was acetonitrile and water (including 0.1% ammonia). The relative standard deviation (RSD) of the intra- and inter-day results ranged from 5.38 to 9.76% and from 6.02 to 9.46%, respectively, and the extraction recovery and matrix effects were calculated to range from 84.31 to 96.14% and from 91.46 to 97.18%, respectively. The results illustrated that the analysis method had sufficient specificity, accuracy and precision. Meanwhile, the UPLC-TOF-MS method for osimertinib was successfully applied into the pharmacokinetics of SD rats. View Full-Text
Keywords: osimertinib; UPLC-TOF-MS; rat; pharmacokinetics osimertinib; UPLC-TOF-MS; rat; pharmacokinetics
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MDPI and ACS Style

Dong, S.-T.; Li, Y.; Yang, H.-T.; Wu, Y.; Li, Y.-J.; Ding, C.-Y.; Meng, L.; Dong, Z.-J.; Zhang, Y. An Accurate and Effective Method for Measuring Osimertinib by UPLC-TOF-MS and Its Pharmacokinetic Study in Rats. Molecules 2018, 23, 2894.

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