使用水友互动液体色谱与充电的气溶探测器相结合,对埃蒂米辛中的杂质进行定量分析
Jiarui Gao1, Quan Wang2, Xinyi Wei3
1Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology, Hangzhou 310014, China.
Journal of pharmaceutical and biomedical analysis
|July 31, 2024
概括
一种新的水友互动液态色谱充电气溶探测器 (HILIC-CAD) 方法提供了对氨基甘油酸抗生素 (AGs) 中杂质的敏感和准确分析. 这种先进的技术克服了旧方法的局限性,确保了药物安全.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 染色体学 染色体学 是一种染色体学.
背景情况:
- 氨基糖化抗生素 (AGs),如乙素是至关重要的,但杂质分析是具有挑战性的.
- 传统的高性能液体色谱与蒸发光散射探测器 (HPLC-ELSD) 方法用于AG杂质,其复制性差,灵敏度低,线性范围窄.
- 这些局限性阻碍了高通量量的定量分析,并对药物安全构成风险.
研究的目的:
- 开发一种灵敏而准确的水友互动液体色谱与充电气溶探测器 (HILIC-CAD) 方法相结合,用于分析乙胺中的杂质.
- 优化HILIC-CAD方法,以提高AG杂质的分离和信号检测.
- 验证该方法的性能,用于定量分析埃蒂米辛和其他AG如伊塞帕米辛和阿米卡辛中的杂质.
主要方法:
- 开发和优化用于Etimicin杂质分析的HILIC-CAD方法.
- 利用盒子-贝恩肯设计 (BBD) 和响应表面方法 (RSM) 来优化液相条件.
- 研究了CAD参数对AG及其杂质的信号噪声比和线性的影响.
主要成果:
- 开发的HILIC-CAD方法实现了令人满意的分离和最佳的CAD输出信号.
- 方法验证表明,在0.5-50微克/毫升范围内,对乙素,伊塞帕素和阿米卡杂质的线性非常好 (R2>0.999).
- 实现了高平均恢复率 (99.03%-101.22%) 和良好的精度 (RSDs <2.5%),表明了准确性和可靠性.
结论:
- HILIC-CAD方法是一种灵敏,准确和高度选择性的技术,用于在不需要离子配对试剂的情况下量化AG中的杂质.
- 这种方法有效地解决了HPLC-ELSD的局限性,改善了AG杂质的分析.
- 这代表了HILIC-CAD在AG中进行定量杂质分析的首次报告应用,提高了公共药物安全.
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