头孢妥仑匹酯有关物质的色谱-质谱结构鉴定

发布时间：2019-07-19 19:13

【摘要】：目的:采用色谱-质谱联用技术鉴定头孢妥仑匹酯的有关物质,为其工艺优化和质量控制提供参考依据。方法:采用YMC-Pack ODS-AM(150 mm×4.6 mm,5μm)色谱柱,以甲醇-乙腈-乙酸铵缓冲液为流动相,梯度洗脱,对头孢妥仑匹酯有关物质进行分离;采用电喷雾正离子化-飞行时间质谱法(ESI-TOF/MS)测定各有关物质离子的准确质量和元素组成,三重四极质谱(ESI-MS/MS)测定子离子特征。结果:在所建立的条件下,头孢妥仑匹酯及其有关物质分离良好,检测并鉴定出10个主要有关物质。结论:色谱-质谱联用技术能有效地分离鉴定头孢妥仑匹酯中的有关物质,鉴定结果为其质量控制和工艺优化提供了参考。
[Abstract]:Objective: to identify the related substances of ceftol by chromatography-mass spectrometry (GC-MS), and to provide reference for its process optimization and quality control. Methods: YMC-Pack ODS-AM (150 mm 脳 4.6 mm, 5 渭 m) column was used, methanol-acetonitrile-ammonium acetate buffer was used as mobile phase, gradient eluting, electrospray positive ionization-time-of-flight mass spectrometry (ESI-TOF/MS) was used to determine the accurate mass and element composition of the ions, and triple quadrupole mass spectrometry (ESI-MS/MS) was used to determine the characteristics of the subions. Results: under the established conditions, ceftol and its related substances were separated well, and 10 main related substances were detected and identified. Conclusion: chromatography-mass spectrometry (GC-MS) can effectively isolate and identify the related substances in ceftopiramate, and the identification results provide a reference for quality control and process optimization.
【作者单位】：中国药科大学药物分析教研室;江苏省食品药品监督检验研究院;江苏省信诺医药对外贸易有限公司;
【分类号】：R927

【相似文献】