通过DoE-DS方法支持的分析方法开发,用于 (S,S) -和 (R,R) -moxifloxacin的对抗分离
Marija Rašević1, Anđelija Malenović1, Ana Protić1
1University of Belgrade, Faculty of Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, Belgrade, Serbia.
Journal of pharmaceutical and biomedical analysis
|August 20, 2023
概括
开发了一种新的方法来测试moxifloxacin化水化合物的反体纯度,该方法使用了phenylcarbamate-β-cyclodextrin奇拉静止阶段. 设计时的分析质量 (AQbD) 和实验设计 (DoE) 确保了方法的稳定性和适用性.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 莫西弗洛克萨辛化是一种第四代诺基诺隆.
- 准确的体纯度测试对于制药质量控制至关重要.
研究的目的:
- 开发和验证一种高度对莫西弗洛克萨辛化水的选择性疗法.
- 应用设计时的分析质量 (AQbD) 原则来开发可靠的方法.
主要方法:
- 使用基酸-β-环氧二烯作为一种基拉尔静止相 (CSP).
- 通过设计 (AQbD) 采用分析质量与实验设计 (DoE) 和设计空间 (DS) 方法.
- 风险评估 (石川,CNX,FMEA) 确定了关键方法参数 (CMP):移动阶段的乙二含量,三乙烯胺含量和水相pH.
主要成果:
- 获得了莫西弗洛克萨辛化的异常反选择性.
- 使用蒙特卡洛模拟定义了一个3D设计空间 (DS).
- 在DS中确定了用于方法验证的最佳工作条件.
结论:
- 开发的选择性方法是稳固的,适合其预期用途.
- AQbD的方法有效指导了可靠的分析试验的开发.
- 经过验证的方法确保了moxifloxacin化的精确反体纯度评估.
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