盐酸阿扎司琼氯化钠注射液中有关物质的研究

Research of related substances in Azasetron hydrochloride and sodium chloride injection

目的鉴定盐酸阿扎司琼氯化钠注射液中的2个未知杂质。方法采用超高效液相串联-四极杆静电场轨道阱质谱技术对杂质Ⅰ、Ⅱ进行结构鉴定,并研究其产生的机理。结果杂质Ⅰ、Ⅱ是阿扎司琼与抗氧剂亚硫酸氢钠在光照条件下产生的杂质。结论结果对盐酸阿扎司琼氯化钠注射液的工艺改进及质量控制具有重要意义。

OBJECTIVE To identify the chemical structure of two unknown impurities in Azasetron hydrochloride and sodium chloride injection(AHSCI).METHODS UPLC-Q-Orbitrap HRMS was adopted to identify the structures of impurityⅠand impurityⅡ.The generation mechanism of the impurities was also studied.RESULTS Impurity I and impurityⅡwere produced by azasetron and antioxidant sodium bisulfite under light conditions.CONCLUSION The results are of significance for manufacturing process and the quality control of(AHSCI).