两种不同的多重双模式逆流色谱仪的比较,用于分离基托可纳酶体
Fuxin Zhang1, Jules Muhire1, Xiao Sun1
1CAS Key Laboratory of Chemistry of Northwestern Plant Resources and Key Laboratory of Natural Medicine of Gansu Province, Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences (CAS), Lanzhou 730000, China; University of Chinese Academy of Sciences, Beijing 100049, China.
Journal of chromatography. A
|February 13, 2024
概括
经过修改的多重双模式 (MDM) 反流色谱显著改善了可纳反体的奇拉分离,实现了基线分离和高反体过量. 这种方法提高了制药分析的分辨率.
科学领域:
- 分析化学 分析化学
- 染色图学技术 染色图学技术
背景情况:
- 药品的 chiral 分离对于有效性和安全性至关重要.
- 凯托可纳 (Ketoconazole) 的反体需要高效的分离方法来进行质量控制.
研究的目的:
- 为了比较常规和修改的多重双模式 (MDM) 反流色谱,用于可纳反分离.
- 优化修改后的MDM方法,以提高合性分辨率和恢复.
主要方法:
- 使用双相溶剂系统 (n-hexane: isobutyl acetate: phosphate buffer) 使用基-β-cyclodextrin作为奇拉选择器.
- 在高速逆流色谱中利用了传统和修改的MDM化模式.
- 通过高性能液体染色学 (HPLC) 确定了等离子过量.
主要成果:
- 与传统的MDM (0.40至0.79) 相比,修改后的MDM化显著提高了分辨率,从0.51到1.19提高了分辨率.
- 在优化修改的MDM条件下实现了基线凯托可纳反体的分离.
- 获得了高回收率 (92.5%的R-(K),83.3%的S-(K)) 和反体过量 (99.0%的R-(K),97.0%的S-(K)).
结论:
- 经过修改的MDM逆流色谱法为基托可纳的奇拉分离提供了卓越的性能.
- 这种技术提供了一种有效和高效的方法来分离具有高纯度的制药反体.
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