使用纳米量分析剂探测器对利博斯塔米辛及其杂质的表征:系统地比较三种不同的气溶探测器的性能
Fei Meng1, Xiaohua Zhou2, Yurong Hou2
1Jiangsu Institute for Food and Drug Control, Nanjing, 210019, China; NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing, 210019, China; School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, 210046, China.
Talanta
|June 9, 2024
概括
使用纳米量分析剂检测器 (NQAD) 的新方法提供了对利博斯塔米辛及其杂质的敏感和准确检测. 这种基于HPLC的方法为复杂抗生素混合物的质量控制提供了经济有效的替代方案.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 像利博斯塔米辛这样的氨基甘油酸抗生素,由于复杂的成分和潜在的有毒杂质,需要仔细表征.
- 气溶探测器对于分析药品样本中常见的非吸收性分析物至关重要.
研究的目的:
- 开发一种可靠,具有成本效益的方法,用于同时检测利博斯塔米及其相关物质.
- 为了评估纳米量分析剂探测器 (NQAD) 与其他气溶探测器相比的性能.
主要方法:
- 高性能液体染色学 (HPLC) 与纳米量分析探测器 (NQAD) 相结合.
- 使用离子对 (PFPA,TFA) 和离子抑制剂优化剂组成.
- 方法验证和与蒸发光散射探测器 (ELSD) 和充电气溶探测器 (CAD) 的比较.
- 使用液体染色学-质谱法 (LC-MS) 进行不纯度结构的表征.
主要成果:
- 与ELSD和CAD相比,NQAD表现出更高的灵敏度 (0.8微克/毫升LOD) 和更广泛的线性范围 (21000微克/毫升).
- 同时检测出具有显著度差异的 рибостамицин和杂质,在单次运行中实现了.
- 由于其线性响应,NQAD提供了更准确的定量结果,优于外部标准和区域规范化方法.
结论:
- 开发的HPLC-NQAD方法是一种灵敏,准确和具有成本效益的替代方案,用于对利博斯塔素及其杂质的常规质量控制.
- 与ELSD和CAD相比,NQAD在复杂的制药系统中对非吸收性分析物的分析提供了更高的性能.
- 该方法促进了抗生素配方的全面表征和质量评估.
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