Lanshoeft, Christian, Heudi, Olivier, Raccuglia, Marc, Leuthold, Luc Alexis, Picard, Franck and Kretz, Olivier (2015) Ultra-fast quantitative mass spectrometry based method for ceritinib analysis in human plasma and its application for clinical use. Bioanalysis. pp. 425-435.

Abstract

Background: We report an ultra-fast method for the quantitative analysis in human plasma of ceritinib, a drug recently approved in the USA for the treatment of non-small-cell lung cancer (NSCLC). Results: Plasma samples were precipitated with acetonitrile containing [13C6]-ceritinib as internal standard and analyzed in 10 seconds each using Laser Diode Thermal Desorption-positive mode Atmospheric Chemical Pressure Ionization tandem mass spectrometry (LDTD-APCI-MS/MS). The method was selective and found to be linear from 5.00-1000 ng/ml using 100 µL plasma. The intra- and inter-days precision and accuracy data met acceptance criteria. The normalized recovery was 69%, carry over and matrix effects were not observed. The method was successfully used to measure clinical samples and consistent data were obtained with the reference LC-ESI-MS/MS method. Conclusions: The developed ultra-fast assay is suitable for quantitative analysis of ceritinib in plasma from clinical trials.

Item Type:	Article
Keywords:	LDTD-APCI; NSCLC; Ceritinib; bioanalysis and validation.
Date Deposited:	13 Oct 2015 13:12
Last Modified:	13 Oct 2015 13:12
URI:	https://oak.novartis.com/id/eprint/22897