在基于酸的HPLC列上分离和识别不同的治疗药物:使用中央复合设计优化方法
Hamide Filiz Ayyildiz1, Fakhar N Memon2, Irfan Ali Mangi2
1Department of Basic Pharmaceutical Sciences, Faculty of Pharmacy, Selçuk University, Konya, Turkey.
Journal of separation science
|May 30, 2023
概括
开发了一种新的混合模式色谱列,使用固定化胺酸进行药物分离. 这种方法为制药应用提供了高精度,选择性和灵敏度.
科学领域:
- 分析化学 分析化学
- 分离科学 分离科学
背景情况:
- 多模色谱对于制药和环境分析至关重要.
- 开发各种药物化合物的高效分离技术是必不可少的.
研究的目的:
- 应用一种新的混合模式列来分离和识别来自不同治疗类的六种药物.
- 评估该列是否适用于制药行业的应用.
主要方法:
- 在aminopropyl silica上使用终端盖的固定酸创建了一个混合模式的列.
- 中心复合设计和二次方格模型被用来优化移动相参数 (酸%,流速,pH).
- 方法验证包括线性,精度,准确性,选择性和敏感性评估.
主要成果:
- 确定了最佳的分离条件:44.8%的乙二,1.75毫升/分钟的流量率和pH7.5,在11分钟内实现了良好的分辨率.
- 开发的方法显示了高精度 (CV>1%),线性 (R2 = 0.99) 和选择性.
- 该方法表现出可接受的灵敏度,具有有利的检测/定量值的极限值.
结论:
- 新的混合模式列可以有效地分离各种药物化合物.
- 开发的染色学方法是精确的,有选择性的,敏感的,适合制药分析.
- 该列的性能与商业替代品相当或优于,这表明其具有强大的工业适用性.
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