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首页> 外文期刊>Journal of chromatography, B. Analytical technologies in the biomedical and life sciences >Determination of rivaroxaban - a novel, oral, direct Factor Xa inhibitor - in human plasma by high-performance liquid chromatography-tandem mass spectrometry
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Determination of rivaroxaban - a novel, oral, direct Factor Xa inhibitor - in human plasma by high-performance liquid chromatography-tandem mass spectrometry

机译：高效液相色谱-串联质谱法测定人血浆中的利伐沙班-一种新颖的口服直接Xa因子抑制剂

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摘要

A high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method allowing the sensitive and specific quantification of rivaroxaban (BAY 59-7939), a Factor Xa inhibitor in advanced development for the prevention and treatment of thromboembolic disorders, in human plasma is described. After precipitation of plasma proteins with methanol containing the internal standard followed by centrifugation, the plasma supernatant was injected directly onto the HPLC-MS/MS system. Concentrations could be determined between 0.50 and 500 mu g/L. Inter-assay precision was <= 7.4% and inter-assay accuracy was between 96.3 and 102.9% throughout the entire working range. The method was applied successfully in several clinical studies, which allowed an accurate determination of rivaroxaban pharmacokinetics in human plasma. (c) 2008 Elsevier B.V. All rights reserved.
机译：一种高效液相色谱-串联质谱（HPLC-MS / MS）方法，用于灵敏性和特异性定量利伐沙班（BAY 59-7939），它是预防和治疗血栓栓塞性疾病的先进Xa因子抑制剂。描述了人类血浆。用含内标物的甲醇沉淀血浆蛋白，然后离心后，将血浆上清液直接注入HPLC-MS / MS系统。浓度可以在0.50至500μg/ L之间确定。在整个工作范围内，批间准确度<= 7.4％，批间准确度在96.3至102.9％之间。该方法已成功应用于多项临床研究中，从而可以准确测定人血浆中利伐沙班的药代动力学。 （c）2008 Elsevier B.V.保留所有权利。

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