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

National Clinical Drug Monitoring Center, Department of Pharmacy, Hebei Province General Center, Shijiazhuang 050051, China
Department of Pharmaceutics, School of Pharmacy, China Medical University, Shenyang 110001, China
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;
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)
PDF [1769 KB, uploaded 6 November 2018]


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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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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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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