溴米那普鲁卡因注射液有关物质检验方法的研究

Study on the detection of related substances of bromisoval and procaine injection

目的:建立溴米那普鲁卡因注射液有关物质检测方法。方法:用LC/UV、LC/MS/MS对未知杂质进行了定性、定量研究。结果:建立了复方制剂有关物质检测方法,溴米那普鲁卡因注射液有关物质主要由溴米索伐引起,并确定了3个未知杂质的可能结构。结论:本法可用于溴米那普鲁卡因注射液有关物质的检测。

Objective：To develop a method for the determination of related substances in Bromisoval and Procaine injection.Method：LC/UV and LC/MS/MS were carried out for qualitative and quantitative researches of unknown impurities.Results：A method for related substances detection of compound preparation was established.The related substances are mainly caused by Bromisoval.The structures of three impurities were initially confirmed.Conclusion：The established method can be used for the determination of related substances in Bromisoval and Procaine Injection.