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


CONCLUSIONS
The new assay is suitable for ceritinib quantification in clinical trials, whereas the analysis time is significantly reduced to 10 s.
Novartis Pharma AG, DMPK/Bioanalytics, Forum 1 Novartis Campus, 4056 Basel, Switzerland.
Christian
C
Lanshoeft
Olivier
O
Heudi
Marc
M
Raccuglia
Luc Alexis
LA
Leuthold
Franck
F
Picard
Olivier
O
Kretz
D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods*; D002986:Clinical Trials as Topic; D006801:Humans; D007834:Lasers; D057230:Limit of Detection; D016014:Linear Models; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods*; D011743:Pyrimidines / Q000097:blood*; D015203:Reproducibility of Results; D013450:Sulfones / Q000097:blood*; D053719:Tandem Mass Spectrometry; D013997:Time Factors
D011743:Pyrimidines; D013450:Sulfones; C586847:ceritinib