Ultrafast quantitative MS-based method for ceritinib analysis in human plasma samples from clinical trial
Christian Lanshoeft1, Olivier Heudi, Marc Raccuglia
1Novartis Pharma AG, DMPK/Bioanalytics, Forum 1 Novartis Campus, 4056 Basel, Switzerland.
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.
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