环保QbD优化的染色法,用于同时分析甲尼达和尼古丁胺胺,并用于透,稳定性和可持续性评估
Kanaka Parvathi Kannaiah1, Mohamed A M Ali2, Hemanth Kumar Chanduluru3
1Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai, 603203, India.
这项研究开发了一种新的,环保的Anaero®凝体外透试验,用于评估甲尼达和尼古丁胺胺的释放. 经过验证的方法证实了凝.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 皮肤病学 皮肤病学
背景情况:
- 亚纳罗®凝结合了 (MTZ) 和尼古丁胺 (NCT) 来治疗和粉红.
- 评估局部配方中的药物释放对于疗效至关重要.
- 现有的方法可能缺乏生态效率或对组合药物分析的敏感性.
研究的目的:
- 开发和验证使用弗朗茨细胞的Anaero®凝的第一个体外透试验 (IVPT).
- 评估从凝中释放的甲尼达和尼古丁胺胺的药物释放特征.
- 评估方法的绿色性和分析性能.
主要方法:
- 带有ODS柱和梯度化 (乙醇/酸盐缓冲区) 的RP-HPLC-PDA.
- 使用两级全因数设计 (2^3 FFD) 的方法优化.
- 根据ICH Q2 (R1) 准则进行验证,并进行全面的绿色评估.
主要成果:
- 在MTZ和NCT方面,IVPT方法表现出良好的线性.
- 对两种药物观察到类似的透模式和系数 (Kp).
- 该方法是稳定的,坚固的,环保的 (使用少量的溶剂,高绿度得分为0.75),敏感的.
结论:
- 开发的IVPT方法适用于评估Anaero®凝的药物释放.
- 该配方对MTZ和NCT都有良好的透特性.
- 这种新,经过验证和绿色分析方法与现有技术相比,提供了更高的性能.
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