Ultrafast quantitative MS-based method for ceritinib analysis in human plasma samples from clinical trial. (March 2015) - Lanshoeft, Christian
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 [ 13 C6 ]-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.