对达卡巴及其相关物质的验证的环保色谱测定
Ibrahim A Naguib1, Eglal A Abdelaleem2, Eman S Hassan2
1Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O.Box 11099, Taif 21944, Saudi Arabia.
Journal of chromatographic science
|November 9, 2025
概括
开发的环保色谱法准确量化达卡巴及其杂质. 这些敏感的,节省时间的技术比现有的HPLC方法提供了环境优势.
科学领域:
- 分析化学 分析化学
- 绿色化学 绿色化学
- 药品分析 药品分析
背景情况:
- 对达卡巴及其杂质的定量确定对于药品质量控制至关重要.
- 现有的方法可能缺乏环境可持续性或效率.
研究的目的:
- 开发和验证敏感,特异和环保的染色学方法,同时确定达卡巴及其与USP相关的杂质.
- 评估绿色特性,并将开发方法的性能与官方标准和现有技术进行比较.
主要方法:
- 逆相高性能液体染色学 (RP-HPLC) 使用C18柱与水:甲醇移动相.
- 高性能薄层染色学 (HPTLC) 在带有绿色发展系统的板上.
- 根据国际协调理事会 (ICH) 的指导方针进行验证.
主要成果:
- 无论是RP-HPLC和HPTLC方法,都实现了同时对达卡巴及其杂质的定量确定.
- 开发的方法显示出高灵敏度,特异性和环保性.
- 达卡巴辛在药物配方 (Dacarbazine medac®注射粉) 中成功量化.
结论:
- 提出的环保RP-HPLC和HPTLC方法适合对达卡巴及其杂质进行准确和同时的分析.
- 与传统的HPLC技术相比,这些方法在环境影响,灵敏度和时间效率方面具有优势.
- 经过验证的方法提供了可靠的结果,与官方的美国药典 (USP) 光谱法相提并论.
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