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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 establish a method for the determination of related substances in bromominil procaine injection. Methods: The qualitative and quantitative studies of unknown impurities were carried out by LC / UV and LC / MS / MS. Results: The detection methods of the related substances of compound preparations were established. The related substances of bromominan procaine injection were mainly caused by bromomicrosofovir, and the possible structures of three unknown impurities were determined. Conclusion: This method can be used for the determination of related substances in bromominan procaine injection.