Bioanalysis Zone

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

0

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.

To view restricted content, please:
Share:

Leave A Comment

Please wait...

Bioanalysis Zone New Investigator Award

Why not start this year by doing something good by nominating an early career scientist for the Bioanalysis Zone New Investigator Award. Complete the details below to register your interest!