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Ultra-fast quantitative mass spectrometry based method for ceritinib analysis in human plasma and its application for clinical use

Lanshoeft, Christian and Heudi, Olivier and Raccuglia, Marc and Leuthold, Luc Alexis and 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

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