Aim: To establish and validate an ultra-high-performance liquid chromatography-tandem mass spectrometry method for the rapid and simultaneous determination of famitinib and its metabolites in human plasma.
Results: All analytes demonstrated good correlation coefficients (R2 > 0.99), and the LLOQ was 0.05 ng/ml. The inter- and intraday accuracy and precision, as well as the stability of the samples, met the requirements of the US FDA. The extraction recovery and the matrix effect ranged from 87.58 to 116.06% and from 84.57 to 120.53%, respectively.
Conclusion: The assay was successfully validated and applied to gastroenteropancreatic neuroendocrine tumor patients, and the assay may be used as a valuable tool in the clinic to determine the drug concentration of famitinib in the plasma of solid tumor patients.
Keywords: UHPLC–MS/MS; famitinib; gastroenteropancreatic neuroendocrine tumors; method validation.