An inter‐laboratory cross‐validation study for the determination of perampanel in human plasma by liquid chromatography assays |
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| Authors: | Yuji Mano |
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| Affiliation: | Drug Metabolism and Pharmacokinetics, Biopharmaceutical Assessment Core Function Unit, Eisai Co. Ltd, Tsukuba‐shi, Ibaraki, Japan |
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| Abstract: | For sample assay to support global clinical studies of perampanel, a novel AMPA receptor antagonist, six chromatographic assay methods in human plasma were developed and fully validated at each laboratory using liquid chromatography with tandem mass spectrometry (LC‐MS/MS) or LC with fluorescence detection (LC‐FL). In this study, samples fortified with known perampanel concentrations were assayed at six laboratories to find whether assay data are comparable. Perampanel was extracted by protein precipitation or liquid–liquid extraction, chromatographed on a reverse‐phase column then detected by MS/MS or FL to achieve the limit of quantification of 0.25 or 1 ng/mL. Cross‐validation samples at four concentrations prepared at a central laboratory were determined at six laboratories and the mean accuracy at each concentration was within ±15% except the low concentration at one laboratory (relative error ?17.4%), suggesting that plasma concentrations of perampanel in clinical trials can be compared across laboratories. |
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| Keywords: | cross‐validation perampanel plasma chromatographic assay |
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