优化绿色稳定性的设计质量范式,表明HPLC方法用于同时确定光素和氧酸盐
Amira H Kamal1, Ahmed A Habib1, Sherin F Hammad1
1Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Scientific reports
|June 28, 2023
概括
一种新的,快速的,环保的染色法准确地分析化和化. 这种稳定性指示方法在四分钟内量化眼科溶液中的药物及其降解产物.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 光素和氧酸是眼科溶液中的关键成分.
- 准确和高效的方法对于药物配方的质量控制和稳定性测试至关重要.
研究的目的:
- 开发一种绿色,坚固和快速的稳定性指示色谱方法,用于同时分析化和化.
- 验证在眼科溶液中量化这些药物的方法,包括在降解产品存在的情况下.
主要方法:
- 利用分数因数和Box-Behnken设计进行方法选和优化.
- 采用了Eclipse Plus C18逆相柱,在220 nm处使用二极管阵列探测器 (DAD).
- 优化移动相组合 (异醇/二二酸缓冲器,pH值3.0),流速 (1.5毫升/分钟) 和柱体温度 (40°C).
主要成果:
- 实现了不到四分钟的快速分析时间.
- 对于两种分析物来说,在指定度范围内表现出极好的线性.
- 通过应力降解研究 (酸性,基本性,氧化条件) 证实了方法的稳定性,平均高回收率 (±SD) 为 99.21±0.74%的氧酸盐和 99.88±0.58%的光素.
结论:
- 开发的方法是一种快速,环保,可靠的稳定性指示测定化和化的化.
- 与此前报告的技术相比,这种方法在速度和环境影响方面具有显著的优势.
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