一种经过验证的超高效液相色谱-串联质谱法，用于定量测定人血浆中一种新型口服表皮生长因子受体（EGFR）抑制剂FCN-411。
A validated ultra-performance LC-MS/MS method for quantifying a novel oral EGFR inhibitor FCN-411 in human plasma.
作者信息
Liu Shuxia, Song Yuanyuan, Wu Di, Lin Lin, Shi Yuankai, Han Xiaohong
机构信息
Department 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.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, PR China.
出版信息
Bioanalysis. 2020 Mar;12(5):295-304. doi: 10.4155/bio-2019-0290. Epub 2020 Mar 18.
To investigate the clinical pharmacokinetic profiles of FCN-411, a new EGFR tyrosine kinase inhibitor, an ultra-performance LC-MS/MS method was developed. 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. 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.
为研究新型表皮生长因子受体（EGFR）酪氨酸激酶抑制剂FCN-411的临床药代动力学特征，开发了一种超高效液相色谱-串联质谱（LC-MS/MS）方法。该方法适用于测定血浆中的FCN-411，因为其样品制备速度快（蛋白质沉淀法），线性范围良好，为2-500 ng/ml，进样量少（5 μl），分析运行时间短（4.5分钟）。根据生物分析方法验证指南，该方法被证明是可接受的。该方法稳健、灵敏且可重复，已准备好应用于I期临床药代动力学研究中FCN-411的测定。
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