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阿奇霉素中有关物质的LC-MS法检测

Determination of Related Substances in Azithromycin by LC-MS

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【作者】 许卓妮李悦沈舜义

【Author】 XU Zhuoni;LI Yue;SHEN Shunyi;State Key Lab. of New Drug and Pharmaceutical Process, Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry;

【机构】 中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点实验室

【摘要】 建立了液相色谱-质谱法分离检测阿奇霉素及其有关物质。采用XBridgeTM C18色谱柱,流动相A为0.3%甲酸溶液(用氨水调至pH 8.2),流动相B为乙腈-甲醇(3∶1),线性梯度洗脱。采用正离子模式采集数据。阿奇霉素与11个已知杂质分离良好。通过强制降解试验考察本法专属性,并对碱降解产物进行结构解析。

【Abstract】 A LC-MS method was established for the determination of azithromycin and its related substances. A XBridgeTM C 18 column was used with the mobile phase A consisting of 0.3% formic acid aqueous solution(adjusted to pH 8.2 by ammonium hydroxide) and mobile phase B consisting of acetonitrile and methanol(3∶1) by gradient elution. The data was acquired in positive ion mode. Good resolution of azithromycin and eleven known related substances was achieved. The specialization of the method was studied and the related substances in azithromycin were determined and elucidated after forced degradation by strong base.

  • 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2013年12期
  • 【分类号】TQ460.72
  • 【被引频次】9
  • 【下载频次】261
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