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使用紫外线和光探测器同时测定 ivabradine 和 metoprolol 的 HPTLC 比较研究

M Rizk¹, Shereen Mowaka^1,2, Mariam Mohamed³

¹Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, 11795, Cairo, Egypt.

|September 14, 2023

概括

一种新的,经过验证的高性能薄层染色法 (HPTLC) 方法可以准确地同时确定伊瓦布拉丁 (IVA) 和甲醇 (MET). 这种敏感的方法适用于制药分析,并为HPLC提供了更绿色的替代方案.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

同时确定多种活性药物成分 (API) 对质量控制至关重要.
现有的方法可能缺乏灵敏度,准确性或环境可持续性.

研究的目的:

开发和验证一种新,简单,准确和敏感的高性能薄层染色学 (HPTLC) 方法.
为了能够同时量化散装和制药配方中的伊瓦布拉丁 (IVA) 和甲醇 (MET).
评估该方法的绿色性,并将其性能与高性能液态染色学 (HPLC) 等既定技术进行比较.

主要方法:

在TLC石板上使用了带有UV吸收和光 (FL) 探测器的HPTLC.
采用一种特殊的开发系统::甲醇:酸:氨 (8.5:1.5:0.2:0.1,v/v).
根据国际协调理事会 (ICH) 的指导方针验证了该方法,包括线性,准确性,精度,选择性,LOD,LOQ和稳定性.

主要成果:

实现了IVA和MET的同时确定,分别具有0.45 ± 0.05和0.89 ± 0.01的明显保留因子 (Rf).
对于UV (50.0-900.0 ng/频段) 和FL (18.0-550.0 ng/频段) 检测模式,在指定的范围内表现出极好的线性.
与HPLC相比,HPTLC方法没有显示出统计学上显著的差异,表明准确性和可靠性相似.

结论:

开发的HPTLC方法是一种简单,准确,敏感和验证的技术,用于同时确定IVA和MET.
该方法遵循绿色分析原则,提供一种潜在的更环保的替代方案.
这种HPTLC方法适用于常规质量控制含有 ivabradine 和 metoprolol 的制药配方.

关键词:

光检测模式的光检测模式绿色评价绿色评价绿色评价这是HPTLC-密度计.伊瓦布拉丁是Ivabradine的一种药物.甲基醇是一种甲基醇.紫外线吸收检测模式的检测模式

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