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验证的LC/MS方法用于同时确定人体血中的埃尔巴斯维尔和格拉索普雷维尔

Aymen Labidi¹, Rafika Bensghaier², Sami Jebali³

¹Laboratoire National de Contrôle Des Médicaments, 11 bis, Rue Jebel Lakhdar Bab Saadoun, 1006 Tunis, Tunisia.

Annales pharmaceutiques francaises

|June 1, 2024

概括

一种新的LC/MS方法准确地量化了人体血中的埃尔巴斯维尔 (ELB) 和格拉索普雷维尔 (GZP). 这种经过验证的方法确保了对患者治疗的精确药物监测.

科学领域:

分析化学分析化学
药理动力学药理动力学

背景情况:

肝炎C病毒 (HCV) 感染需要有效的抗病毒疗法.
埃尔巴斯维尔 (ELB) 和格拉索普雷维尔 (GZP) 是针对HCV的直接作用抗病毒疗法的关键成分.
在生物矩阵中精确量化ELB和GZP对于治疗药物监测和药理动力学研究至关重要.

研究的目的:

开发和验证一种灵敏而准确的液体染色学-并联质谱法 (LC/MS/MS) 方法.
为了确定埃尔巴斯维尔 (ELB) 和格拉索普雷维尔 (GZP) 在人体血中的度.
建立可靠的药理动力学分析和临床应用方法.

主要方法:

使用乙烯酸乙烯制备样品的液体-液体提取.
通过梯度化在水球吸附基柱上实现分离.
使用LC/MS进行检测和量化,使用达克拉塔斯维尔 (DCT) 作为内部标准.

主要成果:

该方法在人体血中对ELB和GZP量化表现出高灵敏度和精度.
验证覆盖了GZP的2-100 ng/mL和ELB的1-50 ng/mL的度范围.
实现了极好的日内和日间精度 (RSD<15%) 和精度 (94.2-107.8%).

结论:

已经成功建立了一种可靠且经过验证的LC/MS方法,用于在人体血中确定ELB和GZP.
这种方法适用于治疗药物监测和ELB和GZP的药理学研究.
验证的试验为临床研究和涉及这些抗病毒药物的患者管理提供了可靠的工具.

关键词:

达克拉达斯维尔 (Daclatasvir) 是一种药物,它可以埃尔巴斯维尔 (Elbasvir) 是一个提取液体液体提取液体格拉索普雷维尔 (Grazoprevir) 是一种药物.人类血是人类的血.在 LC/MS 中使用.液体液体提取液体液体提取药物动力学药物动力学药理动力学药理动力学人类的血.

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