一种可持续的UHPLC-PDA/QTOF-MS方法,用于对阿莫西西林降解杂质的全面分析
Vo Thi Kim Khuyen1, Do Thanh Nhu1, Nguyen Duc Tuan1
1Department of Analytical Chemistry and Drug Quality Control, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
Rapid communications in mass spectrometry : RCM
|February 1, 2026
概括
这项研究开发了一种使用UHPLC-PDA/QTOF-MS的环保分析方法,用于识别阿莫西西林降解杂质. 该方法可确保药物的质量和稳定性,识别新的杂质并支持可持续的制药实践.
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:
- 阿莫西西林是一种广泛的抗生素,容易降解,形成污染物,可能影响药物的稳定性,疗效和安全性.
- 现有的分析方法可能无法充分解决阿莫西林降解产品的全面识别和量化问题.
- 需要生态有效的分析策略来监测阿莫西西林的稳定性并确保药物的质量.
研究的目的:
- 建立一个生态效和全面的分析策略,用于检测和表征阿莫西西林降解杂质.
- 开发和验证UHPLC-PDA/QTOF-MS方法,用于同时确定这些杂质.
- 评估开发的分析方法对环境的影响.
主要方法:
- 优化色谱条件使用软件辅助转换从传统方法.
- 使用Cortecs C18柱与酸的梯度化和pH 5.0缓冲器分离杂质.
- 通过UHPLC-PDA/QTOF-MS.识别和描述降解产品.
- 使用生态尺度,GAPI,AGREE和BAGI工具评估方法对环境的影响.
主要成果:
- 经过验证的UHPLC方法显示出优异的线性,准确性,精度和稳定性,根据ICH Q2 (R2) 准则.
- 确定了四种重要的降解杂质,其中包括两种在当前药典中未列出的新化合物.
- 该方法实现了低检测值 (0.330μg/mL) 和定量值 (0.991μg/mL),适用于阿莫西西林囊中的杂质概况.
- 环境评估证实了该方法的绿色资格,在多种评估工具中获得了高分 (生态规模:78,BAGI:80,GAPI:68,AGREE:0.63).
结论:
- 开发的UHPLC-PDA/QTOF-MS方法提供了增强的染色分辨率,以了解阿莫西西林降解途径.
- 这种分析策略是有效的稳定性评估和常规质量控制的阿莫西西林.
- 该方法通过环保和高效,与可持续发展目标保持一致.
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