改进一些抗高血压药物的常规药物质量控制分析,使用高性能薄层染色学密度计方法与绿色概况评估
Nessreen S Abdelhamid1, Eglal A Abdelaleem1, Adel Lashien2
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.
Journal of separation science
|December 8, 2023
概括
一种新的染色学方法可以准确地同时确定双醇烟酸,卡维迪醇和罗斯米德. 这种简单,具有成本效益的技术适用于抗高血压药物的常规质量控制.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 比索普罗罗醇烟酸和卡维迪洛尔是常见的β-阻断剂,而furosemide是一种利尿剂,经常用作抗高血压剂.
- 准确和同时确定这些药物对于制药配方的质量控制至关重要.
研究的目的:
- 开发和验证一个新的,准确的,同时染色法对比索醇烟酸,卡维迪醇,和furosemide.
- 为常规质量控制建立一个具有成本效益和高效的分析程序.
主要方法:
- 开发了一种新的色谱方法,使用了:甲醇:乙烯酸:氨 (6:2:2:0.2 v/v) 的移动相.
- 检测分离的波段是在240nm进行的.
- 该方法根据国际协调会议的指导方针进行了验证.
主要成果:
- 该方法可以同时分离和确定纯和制药形式的比索普罗醇烟酸盐,卡维迪醇和富洛塞米德.
- 确定了度范围:5-25微克/波段对比索普罗醇烟酸,1-7微克/波段对卡维迪洛,和1-3,5微克/波段对化胺.
- 与现有的反相高性能液态染色学方法的统计比较显示没有显著差异.
结论:
- 开发的染色学方法是第一个同时确定比索醇烟酸,卡维迪和罗西米德的方法.
- 该方法简单,快速,具有成本效益,适用于常规药品质量控制分析.
- 经过验证的方法提供了可靠的结果,与已建立的HPLC技术相提并论.
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