盐酸氨溴索杂质B对照品溶液稳定性的研究  

Stability study on reference standard of impurity B in ambroxol hydrochloride in different solvents

作　　者：张雅军[1] 陈忠兰 孙会敏[1] 王青[1] 吴先富[1] ZHANG Ya-jun;CHEN Zhong-lan;SUN Hui-min;WANG Qing;WU Xian-fu(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2022年第7期699-704,共6页Chinese Journal of New Drugs

摘　　要：目的:对盐酸氨溴索杂质B在不同溶剂中的稳定性进行研究。方法:将盐酸氨溴索杂质B分别溶解于流动相[pH 7.0磷酸盐缓冲液-乙腈(50∶50)]、水、乙腈-水(50∶50)和甲醇中,采用HPLC法测定,考察其色谱纯度随时间变化情况,利用HPLC以及LC-MS对降解产物进行结构鉴定,并从化学反应机理上分析降解过程以及不同溶剂中稳定性差异的原因。结果:盐酸氨溴索杂质B在流动相[pH 7.0磷酸盐缓冲液-乙腈(50∶50)]、水和乙腈-水(50∶50)中不稳定,在甲醇溶剂中稳定,降解产物为盐酸氨溴索,其降解过程以及在不同溶剂中稳定性差异从化学反应机理上得到合理解释。结论:在HPLC法测定盐酸氨溴索有关物质时,建议改用甲醇做溶剂制备样品溶液更为合理。Objective: To study the stability of reference standard of impurity B in ambroxol hydrochloride in different solvents. Methods: Impurity B of ambroxol hydrochloride was dissolved in mobile phase [pH 7.0 phosphate buffer solution-acetonitrile(50∶50)], water, acetonitrile-water(50∶50) and methanol, respectively. Its purity and the change with time were investigated by HPLC. The structure of the degradation product was identified by HPLC and LC-MS. The degradation process and the cause of stability difference in different solvents were analyzed based on the chemical reaction mechanism. Results: Impurity B of ambroxol hydrochloride was unstable in the mobile phase [pH 7.0 phosphate buffer-acetonitrile(50∶50)], water and acetonitrile-water(50∶50), but stable in methanol solvent. The degradation product was ambroxol hydrochloride, and the degradation process and stability difference in different solvents are explained reasonably based on the chemical reaction mechanism. Conclusion: When determining ambroxol hydrochloride-related substances by HPLC, it is reasonable to use methanol as the solvent to prepare sample solution.

关 键 词：盐酸氨溴索杂质B 盐酸氨溴索 结构鉴定 稳定性 

分 类 号：R917[医药卫生—药物分析学]