盐酸氨溴索葡萄糖注射液中未知杂质的分离制备与结构鉴定

Isolation and Identification of An Unknown Impurity Contained in Ambroxol Hydrochloride Glucose Injection

利用超高效液相色谱-二极管阵列检测器法分离制备盐酸氨溴索葡萄糖注射液经高温灭菌产生的未知杂质,以超高效液相-离子阱-飞行时间串联质谱及核磁共振波谱分析对其进行结构表征,最终确定为4-(6,8-二溴-3,4-二氢喹唑啉-3-基)环己醇。研究结果为盐酸氨溴索葡萄糖注射液的质量控制和灭菌工艺优化提供了依据。

An unknown impurity found in ambroxol hydrochloride glucose injection was isolated by UPLC- DAD and identified by UPLC-IT-TOF-MS and NMR analysis. The structure was confirmed to be 4-（6,8-dibromo-3,4- dihydro-quinazolin-3-yl） cyclohexanol. The result could provide a basis for the quality assessment and sterilization process optimization of ambroxol hydrochloride glucose injection.