Ultrafast quantitative MS-based method for ceritinib analysis in human plasma samples from clinical trial
| Autor: | Luc Alexis Leuthold, Marc Raccuglia, Olivier Kretz, Christian Lanshoeft, Olivier Heudi, Franck Picard |
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| Rok vydání: | 2015 |
| Předmět: |
Clinical Trials as Topic
Accuracy and precision Time Factors Chromatography Ceritinib Chemistry Lasers Clinical Biochemistry Reproducibility of Results General Medicine Mass Spectrometry Analytical Chemistry Clinical trial Medical Laboratory Technology Pyrimidines Limit of Detection Tandem Mass Spectrometry Human plasma Linear Models medicine Humans Sulfones General Pharmacology Toxicology and Pharmaceutics Blood Chemical Analysis medicine.drug |
| Zdroj: | Bioanalysis. 7:425-435 |
| ISSN: | 1757-6199 1757-6180 |
| DOI: | 10.4155/bio.14.292 |
| Popis: | 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 [13C6]-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. |
| Databáze: | OpenAIRE |
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