<br>使用 HPLC-MS/MS 比较群多普利、其活性代谢物和维拉帕米在埃及人群血浆中的药代动力学,Drug Testing and Analysis

当前位置： X-MOL 学术 › Drug Test. Anal. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

使用 HPLC-MS/MS 比较群多普利、其活性代谢物和维拉帕米在埃及人群血浆中的药代动力学
Drug Testing and Analysis ( IF 2.6 ) Pub Date : 2018-02-23 , DOI: 10.1002/dta.2357
Ragaa Magdy ₁ , Ahmed H El-Khatib _{2,

3} , Ahmed Hemdan ₁ , Omar Abd Elaziz ₂ , Maha Farouk ₂ , Michael W Linscheid ₃

Affiliation

群多普利和维拉帕米是常用的抗高血压药物。然而，缺乏关于肝或肾功能不全患者药代动力学变化的可用数据，因此需要调整剂量。本文开发并验证了一种高效液相色谱-串联质谱 (HPLC-MS/MS) 方法，用于监测肾功能不全和/或肝功能不全患者血浆中的群多普利、其活性代谢物群多普利拉和维拉帕米不足。色谱分离在 Gemini C ₁₈反相柱上使用梯度洗脱模式实现，运行时间为 10 分钟。流动相由甲醇和 2% 乙酸的混合物组成。电喷雾电离 MS/MS 分析在多反应监测 (MRM) 模式下进行。该检测方法根据美国食品药品监督管理局 (FDA) 的生物分析方法验证指南进行了验证，并被证明适用于测定血浆中治疗药物的水平。将药代动力学数据的组间变化与健康志愿者的变化进行比较。比较显示研究组之间的药代动力学参数存在显着差异。所提出的结果展示了所提出的测定作为连续药物监测的经过验证的分析工具的优点。

"点击查看英文标题和摘要"

Comparative pharmacokinetics of trandolapril, its active metabolite, and verapamil in human plasma of Egyptian population using HPLC–MS/MS

Trandolapril and verapamil are commonly used antihypertensive drugs. However, there is a lack of available data on the change of their pharmacokinetics in patients with liver or kidney impairment and hence the need for dose adjustment. In this article, a high performance liquid chromatography–tandem mass spectrometry (HPLC–MS/MS) method was developed and validated for the monitoring of trandolapril, its active metabolite trandolaprilat, and verapamil in human plasma of patients with renal impairment and/or liver insufficiency. The chromatographic separation was achieved on a Gemini C₁₈ reversed phase column using a gradient elution mode with a run time of 10 minutes. The mobile phase consisted of a mixture of methanol and 2% acetic acid. The electrospray ionization MS/MS analysis was performed in multiple reaction monitoring (MRM) mode. The assay was validated as per Food and Drug Administration (FDA) guidelines for bioanalytical method validation and proved to be suitable for the determination of therapeutic drug levels in plasma. The inter‐group changes in pharmacokinetic data were compared to that of healthy volunteers. The comparison showed a significant difference in the pharmacokinetic parameters between the studied groups. The presented results exhibit the benefits of the proposed assay as a validated analytical tool for the continuous drug monitoring.

更新日期：2018-02-23

点击分享查看原文

点击收藏

阅读更多本刊新发论文本刊介绍/投稿指南