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生物分析方法开发和验证用于估计K3EDTA人类血中的甲福明和维尔达格利普丁,使用HPLCESI-MS/MS/MS

Binit Patel¹, Shalin Parikh², Ravi Patel³

¹Quality Control Department, Hovione, 40 Lake Dr, East Windsor, New Jersey, 08520, USA.

Drug metabolism and bioanalysis letters

|October 20, 2025

概括

一种新的液体染色学-双重质谱法准确地测量了人体血中的甲福林和维尔达格利普丁. 这种经过验证的技术适用于生物等价性研究,确保可靠的药物度分析.

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:

甲福明和维尔达格利普丁是常见的抗糖尿病药物.
在生物矩阵中准确量化这些药物对于药理动力学和生物等价性研究至关重要.

研究的目的:

开发和验证一种灵敏的液体染色学-并联质谱法 (LC-MS/MS) 方法,用于确定人体血中的甲福林和维尔达格利普丁度.
确保该方法符合USFDA临床研究可靠性的生物分析指南.

主要方法:

一个Cosmosil CN柱被用于染色分离与同位素移动相.
检测是使用正离子模式和多反应监测 (MRM) 的电喷射电离化质谱仪进行的.
采用固体相提取 (SPE) 进行样品制备,使用甲胺-D6和维达格利普丁-D7作为内部标准.

主要成果:

该方法实现了美特福林 (89.44%) 和维达格利普丁 (92.26%) 的良好提取回收.
建立了具有高相关系数 (r2 > 0.99) 的线性校准曲线,跨特定范围 (0.5-400 ng/mL用于甲福林,0.2-160 ng/mL用于维达格利普丁).
甲福尔和维达格利普丁的短暂保留时间分别为3.2分钟和3.8分钟,表明了有效的分析.

结论:

开发的LC-MS/MS技术是可靠和有效的量化在人体血中的甲胺和维达格利普丁.
该方法适用于监测涉及这些抗糖尿病药物的生物等价性研究和其他临床研究.

关键词:

生物分析是一种生物分析.这是LC-MS/MS.甲胺是一种甲胺.多反应监测. 多反应监测.固相提取固相提取的方法维尔达格利普丁 (vildagliptin) 是一种药物.

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