甲磺酸帕珠沙星氯化钠注射液中有关物质定性研究

Qualitative study on related substances in pazufloxacin mesylate and sodium chloride injection

目的 通过对甲磺酸帕珠沙星氯化钠注射液中相对保留时间(RRT)约为0.9的未知杂质(杂质A)进行溯源、定性研究和来源分析,以期阐明杂质产生机制,为本品的杂质谱分析和质量控制提供依据。方法 通过高效液相色谱、制备色谱及核磁共振波谱等对本品中杂质A进行溯源和结构解析研究。结果 鉴定出本品中杂质A结构,其为本品原料药合成过程中产生的副产物,此外,对杂质A在原料工艺过程中的产生源头进行分析,制订出杂质A控制策略。结论 本方法测定结果准确可靠,为甲磺酸帕珠沙星氯化钠注射液的杂质谱分析和质量控制提供参考。

Objective To elucidate production mechanism of a unknown impurity(impurity A)with relative retention time(RRT)approximately 0.9 in pazufloxacin mesylate and sodium chloride injection via traceability,qualitative and source analysis,and to provide evidence for the spectrum analysis and quality control of this impurity.Methods High performance liquid chromatography,preparation chromatography,and nuclear magnetic resonance were used to analyze the source and structure of impurity A.Results The structure of impurity A was identified and a byproduct was generated during the synthesis of active pharmaceutical ingredients.In addition,the source of impurity A was analyze.Conclusion This method is reliable,providing a reference for impurity profile analysis and quality control of pazufloxacin mesylate and sodium chloride injection.