甲磺酸瑞波西汀有关物质检测方法的比较

Comparison of Methods for Determination of Related Substances in Reboxetine Mesilate

对甲磺酸瑞波西汀国家食品药品监督管理局标准有关物质的三种检测方法 YBH10432004(试行)、YBH02392008(试行)和YBH09872008进行了对比研究。结果表明,标准YBH10432004(试行)与YBH02392008(试行)检测出混合降解液中杂质个数为10个,主峰拖尾严重,柱效较低;标准YBH09872008检测出混合降解液中杂质个数为12个,主峰峰形对称性较好,柱效较高,与各杂质的分离度能满足要求。

The related substance detection methods of State Food and Drug Administration Standard （Trial） YBHI0432004, YBH02392008 and YBH09872008 for Reboxetine mesylate were compared. The results showed that ten impurities were detected in the mixed degradation solution by the Standard YBH10432004 and YBH02392008, with a training peak and low column efficiency. Twelve impurities were detected by the Standard YBH09872008, with a symmetrical peak and high column efficiency, and the separation of impurities met the requirements.