期刊
BIOANALYSIS
卷 13, 期 19, 页码 1477-1486出版社
Newlands Press Ltd
DOI: 10.4155/bio-2021-0128
关键词
abrocitinib metabolite; APCI; enantioseparation; human plasma
资金
- Pfizer, Inc.
- Syneos Health [7002657-180572.A]
- Pfizer, Inc., New York, NY
- Good Publication Practice (GPP3) [163, 461-464 [2015]]
A chiral HPLC-MS/MS method for quantitation of an active metabolite of abrocitinib in human plasma was validated, showing excellent stability and reproducibility in multiple clinical studies.
Aims: A chiral HPLC-MS/MS method for quantitation of an active metabolite (M2) of abrocitinib was validated in human plasma. Methods: Protein precipitation extraction and normal phase LC with baseline separation of five analytes (abrocitinib; isomeric metabolites M1, M2, M3 and M4) were achieved followed by mass spectrometric quantitation of M2 using positive-mode APCI. Results: With a 5-5000 ng/ml assay range using 100 mu l K(2)EDTA aliquot, the assay provided short (17-min) runtime and robust separation up to approximately 330 injections on one column. Interday and intraday accuracy ranged from -6.80% to 13.4%; between-day and within-day precision was <= 10.4%. Conclusion: The method was used in multiple clinical studies, with excellent run passing rate and incurred sample reproducibility.
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