一种 LC-MS/MS 测定人血浆和泪液中利福替特浓度的方法及其在药代动力学研究中的应用。
An LC-MS/MS method for the determination of Lifitegrast in human plasma and tear and its application in the pharmacokinetic study.
机构信息
Sichuan Institute for Drug Control, Chengdu, 611731, China.
Chengdu Kanghong Pharmaceutical Co. Ltd, Chengdu, 610037, China.
出版信息
Bioanalysis. 2024 Jun 2;16(11):535-544. doi: 10.1080/17576180.2024.2344345. Epub 2024 Jun 6.
Abstract
A new, selective and simple UPLC-MS/MS method was developed and validated for the determination of lifitegrast in human plasma and tear in order to obtain PK data. Lifitegrast-d4 solutions were added in the samples, and then were extracted and transferred to a UPLC vial. The respective working ranges were 25.00-2000.00 pg/ml in plasma and 4.00-1000.00 μg/ml in tear. The fully validated method complied with existing regulatory criteria for accuracy and precision, recovery, etc. It was applied to plasma and tear samples, which were from a clinical study, successfully. This method is useful in the evaluation of lifitegrast in plasma and tear.
摘要
建立并验证了一种新的、选择性好且简单的 UPLC-MS/MS 法，用于测定人血浆和泪液中的利发替斯汀，以获得 PK 数据。在样品中加入利发替斯汀-d4 溶液，然后进行提取并转移到 UPLC 小瓶中。血浆中的相应工作范围为 25.00-2000.00 pg/ml，泪液中的相应工作范围为 4.00-1000.00 μg/ml。该完全验证的方法符合准确度和精密度、回收率等现有监管标准。该方法已成功应用于临床研究中的血浆和泪液样品的测定。该方法可用于评价利发替斯汀在血浆和泪液中的浓度。
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