使用分散和减弱总反射量的量子激光级别光谱来确定活性药物成分的低度的分析方法开发
Plata-Enríquez Jl1,2, Puche-Mercado Jf1, Palmer-Velázquez S1
1Center for Chemical Sensors (CC) / Chemical Imaging and Surface Analysis Center (CISAC), Department of Chemistry, University of Puerto Rico-Mayagüez, Mayagüez, PR 00681, USA.
概括
量子级联激光光谱 (QCLS) 准确地量化了片剂中的乙氨基. 使用QCLS来预测药剂中的活性成分,分散反射率反射比较准确.
科学领域:
- 分析化学
- 光谱学
- 药物分析
背景情况:
- 乙氨基是一种广泛使用的药物活性成分 (API).
- 药物配方中的API的准确量化对于质量控制至关重要.
- 过程分析技术 (PAT) 旨在改善制药制造过程.
研究的目的:
- 使用量子级联激光光谱 (QCLS) 量化低度平板药物配方中的乙胺.
- 为了比较减弱的总反射率 (ATR) 和分散的反射率反射率 (DRB) 的有效性.
- 建立QCLS作为药物应用的PAT中一个有价值的工具.
主要方法:
- 使用常见的辅助剂制备的乙氨基度在0.0%至3.0%之间.
- 使用QCLS在非接触模式下使用中红外光谱 (770-1890厘米-1).
- 使用了减弱总反射率 (ATR) 和扩散反射反射率 (DRB) 技术.
- 使用多变量分析,包括主要成分分析 (PCA),进行校准.
主要成果:
- 在药片配方中QCLS成功分辨和量化了乙胺.
- 与平板分析的ATR相比,扩散反射散射 (DRB) 在预测API含量方面表现出更高的准确性.
- 主要成分分析有效生成了对乙氨基量化的校准模型.
结论:
- QCLS是一种强大的药物分析光谱技术.
- 在中红外QCLS分析中,DRB是首选的方法.
- 在实时药品质量控制过程分析技术 (PAT) 中集成QCLS具有显著的潜力.
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