对于Nebivolol,Valsartan和相关杂质进行了先进的环保光谱分析,并进行了全面的环境影响评估
Abdallah M Hamdy1, Magda M El Henawee2, Hisham Hashem2
1Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, 11829, Cairo, Egypt.
Scientific reports
|May 14, 2025
概括
三种新的光谱光度法为抗高血压药物尼比沃醇化 (NEB) 和瓦尔萨坦 (VAL) 提供了可持续的分析,即使含有杂质. 这些绿色,蓝色和白色分析技术确保了准确的药品质量控制.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 绿色化学 绿色化学
背景情况:
- 制药行业对可持续和环保的分析方法的需求日益增加.
- 在存在瓦尔萨坦德斯瓦莱利 (VAL-D) 杂质的情况下,需要同时量化内比沃洛化 (NEB) 和瓦尔萨坦 (VAL).
研究的目的:
- 开发和优化三种创新的光谱测量技术 (绿色,蓝色和白色) 用于同时分析NEB,VAL和VAL-D.
- 评估开发的分析方法对环境的影响和绿色.
主要方法:
- 优化了三种光谱法:双分数比谱导数,比谱中的双波长和H点导数比.
- 同时测定NEB,VAL和VAL-D,使用三色光谱光度计.
- 使用生态尺度,AGREE和GAPI评估方法的绿色度;使用BAGI的蓝色度;使用RGB12的白色度.
主要成果:
- 已建立的方法在NEB (2.5-70μg/mL),VAL (10-50μg/mL) 和VAL-D (10-70μg/mL) 的指定范围内显示出良好的线性.
- 开发的光谱光计技术根据ICH指南进行了验证,证实了准确性和可靠性.
- 进行了全面的绿色,蓝色和白色评估,表明了方法的环境和分析质量.
结论:
- 拟议的绿色,蓝色和白色光谱法为NEB,VAL和VAL-D的同时分析提供了可持续和准确的方法.
- 这些方法有助于环保的药品质量控制,而不会影响分析性能.
- 统计验证证实了方法的有效性和与现有技术的可比性.
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