全面响应方法用于精确的定量分析类抗生素中的杂质,使用液体染色学与二极管阵列探测器和充电的气溶探测器相结合
Jiarui Gao1, Fan Wang2, Bingqi Zhu3
1Zhejiang University of Technology, Hangzhou 310014, China.
Journal of chromatography. A
|September 27, 2023
概括
一种新的HPLC-DAD-CAD方法在没有参考标准的情况下准确量化诺隆抗生素杂质. 这种方法为这些关键药品提供了灵敏的检测和可靠的质量控制.
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 是一种染色学.
背景情况:
- 高性能液体染色学 (HPLC) 是用于类抗生素杂质分析的标准.
- 量化具有挑战性,因为杂质的紫外线吸收率不同,缺乏参考标准.
- 现有的方法在没有特定标准的情况下,难以准确地进行杂质分析.
研究的目的:
- 开发一种敏感且直接的HPLC方法来分析类抗生素杂质.
- 使用二极管阵列探测器 (DAD) 和充电气溶探测器 (CAD) 进行增强检测.
- 建立一种可靠的方法来控制诺隆抗生素的质量.
主要方法:
- 开发和优化了一种高性能液体色谱与二极管阵列探测器和充电气溶探测器 (HPLC-DAD-CAD) 结合的方法.
- 采用响应表面方法 (RSM) 来优化色谱条件和CAD参数 (雾化温度,波器常数,PFV).
- 验证了线性,回收和精度 (日内和日间) 的方法.
主要成果:
- 在0.5-300μg mL−1.1.9的组件中实现了优异的线性 (r > 0.999).
- 经过证明的高平均恢复率 (DAD为99.02-102.39%,CAD为98.22-101.91%) 和低RSD (<2.5%).
- 开发的HPLC-DAD-CAD方法提供了对杂质的均和公正的反应,无论染色体的差异如何.
结论:
- HPLC-DAD-CAD方法是一种敏感,准确和精确的方法,用于分析类抗生素杂质.
- 这种新的方法克服了变化紫外线吸收的挑战以及对参考标准的需求.
- 开发的方法适用于常规质量控制的诺隆抗生素.
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