Ultrafast quantitative MS-based method for ceritinib analysis in human plasma samples from clinical trial

摘要

Aim: An ultrafast, sensitive, selective and robust LDTD-APCI-MS/MS method was developed for the quantification of ceritinib in human plasma. Results: Samples were protein precipitated using acetonitrile containing [C-13(6)]-ceritinib as internal standard. The assay was validated over a concentration range from 5.00 to 1000 ng/ml. Intra-and inter-day precision and accuracy met acceptance from EMA and US FDA guidelines. The normalized recovery was 69%, whereas no carryover and matrix effects were observed. The method was applied to clinical samples and resultant data were consistent with the LC-ESI-MS/MS reference method. Conclusion: The new assay is suitable for ceritinib quantification in clinical trials, whereas the analysis time is significantly reduced to 10 s.