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在线心切割液相色谱法测定人血浆中的左乙拉西坦:在治疗药物监测中的应用。

Determination of levetiracetam in human plasma by online heart-cutting liquid chromatography: Application to therapeutic drug monitoring.

机构信息

CinnaGen Pharmaceutical, Atasehir, Istanbul, Turkey.

Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Istanbul, Turkey.

出版信息

J Sep Sci. 2020 Sep;43(18):3590-3596. doi: 10.1002/jssc.202000504. Epub 2020 Jul 28.

DOI:10.1002/jssc.202000504
PMID:32644231
Abstract

Levetiracetam is an antiepileptic drug for the treatment of psychiatric patients. In this study, a selective, straightforward, and rapid online heart-cutting liquid chromatography method was developed for the therapeutic drug monitoring of levetiracetam. This method allows for the determination of levetiracetam in human plasma without complex sample preparation. The mobile phases consisted of 30 mM aq. orthophosphoric acid solution/methanol (70:30) at a flow rate of 1 mL/min for the first system and 10 mM aq. orthophosphoric acid solution/methanol (55:45) at a flow rate of 1 mL/min for the second system. The first separation was carried out on a GL Sciences Intersil ODS-3 column (4.6 mm × 150 mm, 3 µm) and the second separation was carried out on a Restek Ultra PFPP column (4.6 mm × 150 mm, 5 µm). The detection was carried out at 205 nm for both systems. The method was validated for selectivity and linearity, which were in the 6-60 µg/mL range. Intra- and interassay accuracies were <112.6%, and the intra- and interassay precisions were <6.4% for all quality control samples. The lower limit of quantitation was 6 µg/mL. The developed method was successfully applied for therapeutic drug monitoring of plasma samples from patients.

摘要

左乙拉西坦是一种抗癫痫药物,用于治疗精神科患者。在这项研究中,开发了一种选择性、直接、快速的在线心切割液相色谱法,用于左乙拉西坦的治疗药物监测。该方法允许在无需复杂样品制备的情况下,在人血浆中测定左乙拉西坦。流动相由 30mM 磷酸水溶液/甲醇(70:30)组成,流速为 1mL/min,第一系统;10mM 磷酸水溶液/甲醇(55:45)组成,流速为 1mL/min,第二系统。第一次分离在 GL Sciences Intersil ODS-3 柱(4.6mm×150mm,3μm)上进行,第二次分离在 Restek Ultra PFPP 柱(4.6mm×150mm,5μm)上进行。两个系统的检测波长均为 205nm。该方法对选择性和线性进行了验证,范围为 6-60μg/mL。所有质控样品的日内和日间准确度均<112.6%,日内和日间精密度均<6.4%。定量下限为 6μg/mL。该方法成功应用于患者血浆样品的治疗药物监测。

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