A simple and selective liquid chromatography- tandem mass spectrometry method for determination of ε-aminocaproic acid in human plasma

G. Moorthy, P. Stricker, A. Zuppa
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引用次数: 1

Abstract

Understanding the clinical pharmacology of the antifibrinolytic drug epsilon-aminocaproic acid (EACA) is critical for rational drug administration in children. The aim of this study is to develop a reliable assay for the determination of EACA in human plasma. We describe a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) assay for EACA in human plasma. Sample preparation involved plasma dilution (1:2040), followed by reversed-phase chro- matographic separation and selective detection using tandem mass spectrometry. EACA had a linear range of 1 - 250 µg/mL. The intraday precision based on the standard deviation of replicates of quality control samples ranged from 4.7 to 10.4% and the accuracy ranged from 92-106%. The interday precision ranged from 4.6 to 9.8% and the accuracy ranged from 95-103%. Stability stud- ies showed that EACA was stable during the conditions for sample preparation and storage. The described method is robust and successfully employed for clinical studies of EACA in children.
一种简单选择性液相色谱-串联质谱法测定人血浆中ε-氨基己酸
了解抗纤溶药物epsilon-氨基己酸(EACA)的临床药理学对儿童合理用药至关重要。本研究的目的是建立一种可靠的测定人血浆中EACA的方法。我们描述了一种高效液相色谱-串联质谱(HPLC-MS/MS)测定人血浆中EACA的方法。样品制备包括血浆稀释(1:40 0),然后进行反相色谱分离和串联质谱选择性检测。EACA在1 ~ 250µg/mL范围内呈线性关系。以重复质控样品标准偏差为基础的日内精密度为4.7 ~ 10.4%,准确度为92 ~ 106%。日间精密度为4.6 ~ 9.8%,准确度为95 ~ 103%。稳定性研究表明,EACA在样品制备和储存条件下是稳定的。该方法稳健性好,成功地应用于儿童EACA的临床研究。
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