一个简单的开启-关闭光方法,用于药物片中的fluvoxamine的测定;应用到内容统一性测试
Sayed M Derayea1, Mohamed Oraby2, Al Amir S Zaafan2
1Analytical chemistry Department, Faculty of pharmacy, Minia University Minia 61519 Egypt.
RSC advances
|March 12, 2024
概括
一种新的绿色光谱法测量方法使用红素B量化伏胺. 这种经过验证的方法准确地测量了抗抑郁药的剂量形式,即使是辅助剂.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 精确量化抗抑郁药物,如fluvoxamine对于治疗疗效和患者安全至关重要.
- 开发环保的分析方法是制药分析中日益增长的趋势.
研究的目的:
- 建立一个绿色的,光谱法测量方法来量化fluvoxamine.
- 为了验证其在药物配方中的应用而开发的方法.
主要方法:
- 在乙酸缓冲器中形成流胺和乙红B之间的关联复合物.
- 在530nm激发和552nm发射时测量Erythrosine B的光火.
- 根据ICH指南,优化反应条件和验证.
主要成果:
- 观测到光火和流胺度 (0.2-2.0μg mL−1) 之间的线性关系,r = 0.9998.
- 低检测极限 (0.03μg mL-1) 和量化极限 (0.09μg mL-1).
- 成功应用于具有高回收率 (98.92 ± 0.87%) 和内容统一性测试的药物剂型.
结论:
- 开发的绿色光谱法是灵敏的,准确的,适合用于药品制剂中黄素的常规质量控制.
- 该方法能够进行内容统一性测试,这突显了其实用性的实用性.
- 这种方法为流胺分析提供了一个环保的替代方案.
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