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基于LC-MS/MS在老鼠血中同时量化甲和西尼迪平:药理动力学评估,绿色分析评估和DoE驱动的优化

Sravanthi Gandu¹, Kumaraswamy Gandla¹, Lalitha Repudi¹

¹Department of Pharmacy, Chaitanya (Deemed to be University), Gandipet, Himayathnagar (Vill), Monabad (Mandal), Hyderabad 500075, RangaReddy(Dist), Telangana, India.

Journal of pharmacological and toxicological methods

|September 27, 2025

概括

开发了一种新的液体染色学-并联质谱法 (LC-MS/MS) 方法,用于量化大鼠血中的甲基和西尼迪平. 这种优化的方法可确保在临床前药物动力学研究中进行准确的药物分析.

科学领域:

分析化学分析化学
药理动力学药理动力学
质谱测量质量谱测量

背景情况:

同时量化chlorthalidone和cilnidipine对于理解它们的联合药理动力学特征至关重要.
现有的分析方法可能缺乏临床前药物开发所需的灵敏度,可重复性或稳定性.

研究的目的:

开发和验证一种高度灵敏和可重复的LC-MS/MS方法,用于同时量化大鼠血中甲和西尼迪平的含量.
通过设计质量 (QbD) 框架和实验设计 (DoE) 优化方法,以提高分析稳定性.
在临床前模型中应用这些药物的药理动力学评估的经过验证的方法.

主要方法:

液体染色学-并联质谱学 (LC-MS/MS) 用于同时量化.
设计质量 (QbD) 框架和盒式设计 (Box-Behnken Design) 被用于方法优化.
方法验证是根据欧洲药物管理局 (EMA) 的指导方针进行的,评估了线性,准确性,精度和稳定性.

主要成果:

一种优化的LC-MS/MS方法实现了对chlorthalidone和cilnidipine的敏感和可重复量化.
最佳条件包括20%的有机含量,1.0毫升/分钟的流量和pH 3.0移动阶段.
经过验证的方法表现出极好的线性 (r2 > 0.998),准确性和精度 (CV <10%),具有良好的分析剂稳定性.

结论:

开发的DoE优化的LC-MS/MS方法具有选择性,可靠性,适合临床前药理动力学研究.
这种分析平台提供了一个环保的解决方案,用于评估chlorthalidone和cilnidipine.
该方法的稳定性和灵敏性支持其在药物开发和监管提交方面的应用.

关键词:

甲基化物.这种药物是 Cilnidipine.专家设计的设计绿色分析化学绿色分析化学这是LC-MS/MS.药物动力学药物动力学

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