A validated ultra-performance LC-MS/MS method for quantifying a novel oral EGFR inhibitor FCN-411 in human plasma
Shuxia Liu1,2, Yuanyuan Song2, Di Wu2
1Department of Clinical Laboratory, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, PR China.
Abstract:
Aim: To investigate the clinical pharmacokinetic profiles of FCN-411, a new EGFR tyrosine kinase inhibitor, an ultra-performance LC-MS/MS method was developed. Methods & results: The method was suitable to determine FCN-411 in plasma due to the fast sample preparation (protein precipitation procedure), a good linear range of 2-500 ng/ml, low amount of sample volume (5 μl) and less run time (4.5 min) for analysis. And it was demonstrated to be acceptable according to the guidelines for bioanalytical assay validation. Conclusion: The method was robust, sensitive and repeatable, and it is ready to be applied to measure FCN-411 in a Phase I clinical pharmacokinetic study.
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