药物片中的API含量在毫秒内通过时间延伸近红外传输光谱学量化
Koji Nakayama1, Junki Sahara2, Masaya Fujimoto1
1Production Division, Manufacturing Technology Department, Towa Pharmaceutical Co., Ltd., 3-8 Matsuo, Kadoma, Osaka 571-0044, Japan.
Journal of pharmaceutical and biomedical analysis
|July 30, 2024
概括
我们开发了一种新的近红外 (NIR) 光谱仪,用于快速准确地量化药片中的活性药物成分 (API). 这项技术提高了药物可靠性,样本的影响最小.
科学领域:
- 分析化学 分析化学
- 频谱学是一种光谱学.
- 药品分析 药品分析
背景情况:
- 确保药品质量取决于药品活性成分 (API) 的准确量化.
- 传统的API量化方法可能耗时,阻碍快速质量控制.
- 近红外 (NIR) 光谱技术提供了一种具有高速测量潜力的非破坏性分析技术.
研究的目的:
- 评估新型高功率NIR时间延伸传输光谱仪的可行性,以快速准确地量化药片中的API.
- 评估这种新型光谱仪的性能与已建立的方法比如里埃变换NIR (FT-NIR) 光谱.
- 为了确定NIR脉冲对平板样本的影响.
主要方法:
- 开发和使用定制的高功率NIR时间延伸传输光谱仪.
- 应用一个多变量校准模型来量化API内容.
- 测量时间和精度与标准的富里埃变换NIR (FT-NIR) 光谱仪的比较.
- 在NIR脉冲照射后评估样品完整性.
主要成果:
- 成功量化模型药物片中的API含量,每片测量时间仅为3.9毫秒.
- 实现了与传统的FT-NIR光谱仪相美的量化准确度,每次测量需要几秒钟.
- 证明新光谱仪使用的NIR脉冲对平板样本的影响微不足道.
- 证实了开发的NIR时间延伸传输光谱仪的高速和高精度能力.
结论:
- 新型NIR时间延伸传输光谱仪是一个可行的工具,用于制药片中的高速,高精度的API量化.
- 与传统方法相比,这种技术显著减少了测量时间,提高了药品质量控制的效率.
- 该方法非破坏性且可靠,有助于提高制药产品的可靠性.
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