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可持续分析的范式:QbD驱动的HPLC-DAD用于制药,生物和环境样本中的三重抗过敏剂

Aya Magdy Saad¹, Jenny Jeehan Mohamed Nasr¹, Asmaa Kamal El-Deen²

¹Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

|October 28, 2025

概括

本研究介绍了一种使用HPLC-DAD的设计质量 (Quality by Design,简称QbD) 方法,用于分析抗过敏疗法中的特拉尼拉斯,普拉诺和胺马莱酸盐. 经过验证的方法确保了可靠的质量控制,并支持更绿色的分析实践.

科学领域:

分析化学分析化学
制药科学制药科学
绿色化学绿色化学

背景情况:

抗过敏组合疗法需要强大的分析方法来进行质量控制.
传统方法可能缺乏效率和可持续性.
设计质量 (QbD) 为方法开发提供了一种系统的方法.

研究的目的:

开发和验证对特拉尼拉斯 (TNL),普拉诺 (PPF) 和胺酸 (CPM) 的同时分析方法.
应用设计质量 (QbD) 原则来优化HPLC-DAD方法.
评估该方法的可持续性和适用于复杂矩阵的适用性.

主要方法:

使用二极管阵列检测 (HPLC-DAD) 的高性能液体染色学.
设计质量 (QbD) 框架用于方法优化 (移动阶段,流速,温度).
符合ICH指导方针的方法验证和对眼滴,水性幽默和水样的应用.

主要成果:

成功实现了TNL,PPF和CPM的同时分离.
经过验证的方法显示出出色的线性,低的检测/量化极限.
在各种样本矩阵中,恢复率高 (>97%).
QbD应用增强了方法可靠性和一致性.

结论:

优化QbD的HPLC-DAD方法为抗过敏组合疗法的质量控制提供了一种高效可靠的工具.
该方法与绿色分析化学原则保持一致,为环境和经济带来好处.
这种方法有助于开发更安全,更有效的抗过敏眼科配方.

关键词:

盒子-Behnken设计的设计.环境分析环境分析绿色是绿色的绿色是绿色的创新创新创新创新创新创新创新从设计开始的质量.

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