文章摘要
梅雪娇,闫翔宇,严相平.盐酸氨溴索注射液降解杂质结构与降解途径分析[J].药学与临床研究,2022,30(4):305~308
盐酸氨溴索注射液降解杂质结构与降解途径分析
Analysis of Structure and Degradation Pathway of Degradation Impurities in Ambroxol Hydrochloride Injections
投稿时间:2022-03-24  修订日期:2022-08-22
DOI:
中文关键词: 盐酸氨溴索  降解杂质  降解途径  质谱
英文关键词: Ambroxol hydrochloride  Degradation of impurities  Degradation pathway  Mass spectrum
基金项目:
作者单位E-mail
梅雪娇 江苏省药物研究所有限公司 597336258@qq.com 
闫翔宇 江苏省药物研究所有限公司  
严相平 南京科技职业学院 yanxpsci002@163.com 
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中文摘要:
      目的:对盐酸氨溴索注射液在氧化和光照条件下强制破坏产生降解杂质的结构和来源进行研究。方法:通过对盐酸氨溴索注射液在各条件下进行强制破坏,产生降解杂质,采用VisionHT C18色谱柱(250 mm × 4.6 mm,5 μm)。以0.01 mol·L-1磷酸氢二铵溶液(用磷酸调节pH至7.0)-乙腈(50∶50)洗脱,分离制备有关物质,采用质谱法,对主要降解产物的结构进行研究。归属杂质来源,推测形成路径。结果:确定了盐酸氨溴索注射液中8个降解杂质的分子结构,并明确了其质谱裂解反应机理。结论:成功推测了盐酸氨溴索注射液强制氧化和光降解产物的结构,并阐明其产生的路径。
英文摘要:
      Objective: To study the structure and source of degradation impurities produced by forced destruction of ambroxol hydrochloride injections under oxidation or light conditions. Methods: Degradation impurities were produced through forced destruction of ambroxol hydrochloride injections under oxidation or light conditions. The related substances were separated on an Vision HT C18 chromatographic column (250 mm × 4.6 mm, 5 μm) by eluting with 0.01 mol·L-1 diammonium hydrogen phosphate (adjust the pH to 7.0 with phosphoric acid)-acetonitrile (50∶50). The structures of the main degradation products were studied by mass spectrometry. The sources and formation paths of impurities were speculated. Results: The molecular structures of eight degradation impurities of ambroxol hydrochloride injections were determined, and their mass spectrum cleavage reaction mechanisms were clarified. Conclusions: The product structures of forced oxidation and photodegradation of ambroxol hydrochloride injections were successfully speculated with production pathway clarified.
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