盐酸艾司洛尔注射液中杂质的分离、合成与结构鉴定

目的: 研究盐酸艾司洛尔注射液中杂质的结构和产生的原因。 方法: 采用制备高效液相色谱方法制备分离盐酸艾司洛尔注射液的杂质并采用IR、MS、¹H-NMR、¹³C-NMR等方法进行结构鉴定;合成制备了此杂质并进行结构确证。 结果: 该杂质为4-｛ ]丙氧基｝苯丙酸盐酸盐,为盐酸艾司洛尔注射液在储藏过程的降解产物。 结论: 本研究可为盐酸艾司洛尔注射液质量评价提供依据。

Objective: To identify the structure and source of the impurity of esmolol hydrochloride injection. Methods: The impurity of esmolol hydrochloride injection was separated by prep-HPLC,and its structure was identified by IR,MS,¹H-NMR,¹³C-NMR;The impurity was synthesized and the structure was identified. Results: The impurity of esmolol hydrochloride injection is confirmed to be 4-{ \]propoxy} benzenepropanoic acid methyl ester hydrochloride;It is degradation product of the esmolol hydrochloride injection in the process of storage. Conclusion: The study may be provided theoretical basis for quality assessment of the esmolol hydrochloride injection.