Clinical Assay Group, Global Product Development, Pfizer, Inc., Groton, CT 06340, USA.
Syneos Health Clinical Laboratories, Princeton, NJ 08540, USA.
Bioanalysis. 2021 Oct;13(19):1477-1486. doi: 10.4155/bio-2021-0128. Epub 2021 Oct 4.
A chiral HPLC-MS/MS method for quantitation of an active metabolite (M2) of abrocitinib was validated in human plasma. 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. With a 5-5000 ng/ml assay range using 100 μl KEDTA 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%. The method was used in multiple clinical studies, with excellent run passing rate and incurred sample reproducibility.
一种手性 HPLC-MS/MS 方法用于定量阿泊替尼的活性代谢物（M2）在人血浆中的含量。采用蛋白沉淀提取和正相 LC 进行分析，实现了 5 种分析物（阿泊替尼；异构体代谢物 M1、M2、M3 和 M4）的基线分离，然后采用正离子模式 APCI 对 M2 进行质谱定量。使用 100 μl KEDTA 等分试样，检测范围为 5-5000 ng/ml，该方法提供了短（17 分钟）的运行时间和强大的分离能力，在一根色谱柱上可进行约 330 次注射。日间和日内准确度范围为-6.80%至 13.4%；批间和批内精密度均≤10.4%。该方法已在多项临床研究中使用，具有出色的运行通过率和重现性。
