HPLC-MS分析注射用头孢硫脒中的杂质
于明艳;凌霄
【期刊名称】《食品与药品》 【年(卷),期】2017(019)002
【摘要】Objective To establish an HPLC-MS method for the analysis of the polymers and related impurities in Cefathiamidine for Injection. Methods The HPLC was performed on a polystyrene gel (MKF-GPC, 7.8 mm×30 cm, 7 μm)with 10 mmol/L ammonium acetate-acetonitrile (80:20) as mobile phase. Data was collected under positive/negative ion mode with ESI as ion resource.Results The structures of the polymers and related impurities in Cefathiamidine for Injection was analyzed by first order mass spectrum. Conclusion A new method is established for analysis of the polymers and related impurities in Cefathiamidine for Injection, and thus can provide reference for quality control and process optimization.%目的 采用液相色谱-质谱联用技术(HPLC-MS)分析注射用头孢硫脒中的高分子聚合物及相关杂质.方法 色谱柱为MKF-GPC凝胶色谱柱(7.8 mm×30 cm,7μm),流动相为10 mmol/L乙酸铵溶液-乙腈(80:20);离子源:ESI离子源;扫描模式:正/负离子扫描.结果 通过一级质谱图分析了注射用头孢硫脒中可能存在的高分子聚合物及相关杂质的分子结构.结论 本研究为分析注射用头孢硫脒中高分子聚合物及相关杂质提供了一种新方法,进而可为药品杂质控制和工艺优化提供参考.
【总页数】5页(102-106)
HPLC-MS分析注射用头孢硫脒中的杂质
