胶束电动色谱检测注射用哌拉西林钠三唑巴坦钠的杂质谱

摘要

目的 针对现行HPLC方法的不足之处,采用胶束电动色谱技术检测注射用哌拉西林钠三唑巴坦钠的杂质谱.方法 方法建立过程中分别采用压力辅助-胶束电动色谱和短端进样法对药品中的有关物质进行筛查,以便得到较为完整的杂质谱和分析目标；为证实分离系统的专属性和有效性,分别采用杂质对照品、半制备HPLC和梯度洗脱HPLC-电喷雾离子阱质谱对杂质谱中的主要杂质进行了确认.结果 采用该方法,9个已知杂质、其他未知杂质、哌拉西林以及三唑巴坦之间均分离良好.新方法可对注射用哌拉西林钠三唑巴坦钠的杂质进行更为有效而全面的分离分析.结论 该方法可应用于注射用哌拉西林钠三唑巴坦钠的杂质谱检测.%Objective Considering the shortcoming of current HPLC methods, a micellar electrokinetic chromatography method was established to detect the impurity profile of piperacillin sodium and tazobactam sodium for injection. Methods In order to obtain full impurity profile, the pressure-assisted micellar electrokinetic chromatography and the "short-end-injection" technique were utilized during the method development. Impurity reference standards, semi-preparative HPLC, and gradient HPLC-electrospray ion trap mass spectrometry were used to confirm the selectivity and validity of the separation system. Results The novel method could provide efficient and comprehensive separation for the impurities of piperacillin sodium and tazobactam sodium for injection. Conclusion Using the novel method, nine known impurities, other unknown impurities, piperacillin and tazobactam could be separated. This method can be used for the impurity profiling of piperacillin sodium and tazobactam sodium for injection.