在局部配方中同时确定一般活性成分,采用燃烧电离检测 (GC-FID) 的气相色谱
Anna Ioutsi1, Anastasia Sarnitskaya1, Mikhail Sumtsov1
1Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Federal State Budgetary Institution, 8/2 Petrovsky Blvd, Moscow 127051, Russian Federation.
一种新的气体染色法准确量化了局部配方中的多种活性成分. 这种经过验证的方法提供了一种简单,快速和灵敏的方法来控制奶油和药膏的质量.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 局部配方需要精确量化活性药物成分 (API).
- 现有的分析方法可能缺乏敏感性或效率,无法同时确定具有不同波动性的多个API.
研究的目的:
- 开发和验证一种简单,快速,精确和敏感的气相色谱 (GC) 方法.
- 允许使用单一方法同时确定局部配方中的低沸点和高沸点API.
主要方法:
- 气相色谱 (GC) 用于分析.
- 方法优化涉及评估各种染色学参数和样本准备技术.
- 验证是按照国际协调理事会 (ICH) 的指导方针进行的.
主要成果:
- 该方法成功确定了坎佛,L-薄荷,甲基酸盐,酸,酸尼古丁酸和nonivamide.
- 达到的量化极限范围从0.7μg/mL (基尼古丁酸盐,L-醇) 到41μg/mL (酸).
- 证明了高可重复性和良好的回收值,表明方法的稳定性.
结论:
- 开发的GC方法适用于局部配方的质量控制,如药膏和奶油.
- 这种单一的分析方法有效量化了具有不同沸点的多个API.
- 经过验证的方法符合制药分析的监管标准.
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