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μPESI-MS/MS 系统用于血浆样品中药物的筛选和定量。

μPESI-MS/MS System for Screening and Quantitating Drugs in Plasma Samples.

机构信息

Guangdong Provincial Key Laboratory of New Drug Design and Evaluation, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong China, 510006.

Guangdong RangerBio Technologies Co., Ltd., Dongguan, Guangdong China, 523000.

出版信息

J Am Soc Mass Spectrom. 2023 Jul 5;34(7):1295-1304. doi: 10.1021/jasms.3c00025. Epub 2023 Jun 20.

Abstract

Recently, we developed a novel microprobe electrospray ionization (μPESI) source and its coupled MS (μPESI-MS/MS) system. Here, we aimed to widely validate the μPESI-MS/MS method for quantitative analysis of drugs in plasma samples. Furthermore, the relationship between the quantitative performance of the μPESI-MS/MS method and the physicochemical properties of target drugs was analyzed. The μPESI-MS/MS methods for quantitative analysis of 5 representative drugs with a relatively wide range of molecular weight, p, and log  values were developed and validated. The results showed that the linearity, accuracy, and precision of these methods met the requirements of the European Medicines Agency (EMA) guidance. Then a total of 75 drugs from plasma samples were primarily detected using the μPESI-MS/MS methods, among which 48 drugs could be quantitatively measured. Logistics regression suggested that drugs with significantly greater log  and physiological charge had better quantitative performance using the μPESI-MS/MS method. Collectively, these results clearly demonstrate the practical application of the μPESI-MS/MS system as a rapid approach to the quantitative analysis of drugs in plasma samples.

摘要

最近,我们开发了一种新型的微探针电喷雾电离(μPESI)源及其耦合的 MS(μPESI-MS/MS)系统。在这里,我们旨在广泛验证 μPESI-MS/MS 方法在血浆样品中药物定量分析的适用性。此外,还分析了 μPESI-MS/MS 方法定量性能与目标药物理化性质之间的关系。开发和验证了用于定量分析 5 种代表性药物的 μPESI-MS/MS 方法,这些药物的分子量、p 值和 log 值范围较宽。结果表明,这些方法的线性、准确性和精密度均符合欧洲药品管理局(EMA)指南的要求。然后,使用 μPESI-MS/MS 方法对来自血浆样品的总共 75 种药物进行了初步检测,其中 48 种药物可定量测量。逻辑回归表明,具有较大 log 值和生理电荷的药物使用 μPESI-MS/MS 方法具有更好的定量性能。总之,这些结果清楚地表明 μPESI-MS/MS 系统作为一种快速定量分析血浆样品中药物的方法具有实际应用价值。

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