Ultrafast quantitative MS-based method for ceritinib analysis in human plasma samples from clinical trial. (March 2015)

• Record Type: Journal Article
• Authors: Lanshoeft, Christian; Heudi, Olivier; Raccuglia, Marc; Leuthold, Luc Alexis; Picard, Franck; Kretz, Olivier
• Is Part Of: Bioanalysis. Volume 7:Number 4(2015)
• Page Start: 425
• Page End: 435
• Publication Date: 2015-03
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.14.292
• Languages: English
• ISSNs: 1757-6180

Abstract

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.