A simple isotope-labeled UHPLC-MS/MS assay for simultaneous quantification of methotrexate, imatinib and dasatinib.

Yao Zhang, Yao Liu, Lu Tan

Bioanalysis 2021 Oct

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Aim: To assist therapeutic dose adjustment in clinic, a reliable concentration measurement is quite necessary for therapeutic drug monitoring. Results: A UHPLC-MS/MS bioassay for simultaneous determination of methotrexate, imatinib and dasatinib using isotope dilution internal standardization has been established and fully validated as per China Food and Drug Administration guideline. After a simple protein precipitation, the analytes were separated by a gradient elution within 3 min and mass detection was performed via ESI+ mode with SRM. The calibration curves were in the range of 5-100 ng/ml for methotrexate, 25-5000 ng/ml for imatinib and 1-250 ng/ml for dasatinib. Imprecision and inaccuracy values were ≤9.44% and ≤12.81% for all analytes, respectively. Conclusion: The developed method is appropriate for therapeutic drug monitoring, being applied to help individualized therapy in patients with acute lymphoblastic leukemia.

Citation

Yao Zhang, Yao Liu, Lu Tan. A simple isotope-labeled UHPLC-MS/MS assay for simultaneous quantification of methotrexate, imatinib and dasatinib. Bioanalysis. 2021 Oct;13(19):1501-1510