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Determination of asundexian and its metabolite M-10 in human plasma by LC–MS/MS: supplementary materials

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posted on 2023-04-11, 17:44 authored by Lukas Fiebig, Sabine Helmes, Michael Kaiser, Daniel Werner

Background: The authors present a validated method for the simultaneous quantification of asundexian

(BAY 2433334) and its pharmacologically inactive major human metabolite M-10 from human plasma and

its application in clinical study sample analysis. Materials & methods: Sample preparation was performed

by protein precipitation followed by reverse phase HPLC and positive/negative ESI-MS/MS. Results: Assay

working ranges were 0.5–500 ng/ml for asundexian and 5.0–5000 ng/ml for M-10. Validation results

met the requirements of pertinent guidelines. In clinical study sample analysis, accuracy and precision

acceptance criteria for analyzed quality control samples were met and incurred sample reanalysis was

fulfilled. Conclusion: The method proved to be selective, specific, sufficiently sensitive, reproducible and

robust for the analysis of samples obtained from clinical trials.