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使用染色学方法研究大脑血管扩展药物的稳定性:评估方法的实用性和环境方面

Amal M Al-Mohaimeed¹, Maha F El-Tohamy¹, Mohamed G H Ali²

¹Department of Chemistry, College of Science, King Saud University, P.O. Box 22452, Riyadh 11495, Saudi Arabia.

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

|November 20, 2024

概括

维恩伯宁 (VNB) 是一种血管扩张剂,在性条件下降解为碳酸衍生物. 开发了新的绿色分析方法 (TLC-密度计和RP-HPLC) 来量化VNB及其降解产物.

科学领域:

分析化学分析化学
药品分析药品分析
绿色化学绿色化学

背景情况:

维恩伯宁 (VNB) 是一种作为血管扩张剂的葡萄酒类.
VNB易受水解性降解,特别是在性环境中,形成碳酸衍生物 (DEG).
准确量化VNB及其降解产品对于质量控制至关重要.

研究的目的:

开发和验证新的,绿色的分析方法,用于同时量化温伯宁 (VNB) 和其性降解产物.
在特定条件下评估VNB的降解概况.
评估开发的分析方法对生态的影响.

主要方法:

使用凝60 F254板和乙烯酸乙烯的移动相:甲醇:三乙烯 (6:4:0.05,v/v) 的TLC密度测试的开发,检测在230nm.
开发一种逆相HPLC (RP-HPLC) 方法,使用C8柱与甲醇:水 (95:5,v/v) 移动相,流量为1mL/min,在230nm处检测UV.
应用绿色分析指标 (NEMI,分析生态尺度,GAPI,BAGI) 来评估方法对环境的影响.

主要成果:

开发的TLC-密度计和RP-HPLC方法成功量化了VNB及其降解产物.
这些方法预测了VNB在性介质中的降解行为.
统计分析显示,拟议方法与参考HPLC方法之间没有显著差异.
所有开发的方法都符合ICH验证指南.

结论:

新的绿色TLC-密度计和RP-HPLC方法已成功开发,用于同时分析VNB及其降解产物.
这些方法适用于药物配方中VNB的质量控制和稳定性研究.
开发的测试是环保的,符合监管要求.

关键词:

绿色的个人资料绿色的个人资料在RP-HPLC中使用.稳定性指示方法的稳定性表示方法这就是TLC.维恩伯尼尼 (Vinburnine) 是一个葡萄酒.

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