LC-MS/MS法对法罗培南钠中有关物质的研究
Identification of the related substances in faropenem sodium by LC-MS/MS
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摘要: 采用LC-MS/MS法对法罗培南钠中有关物质进行鉴定研究。采用Lichrospher ODS-3色谱柱(250 mm×4.6 mm,5 μm)，以0.2%醋酸铵-0.5%甲酸水溶液-乙腈为流动相，线性梯度洗脱，对法罗培南钠有关物质进行分离；LC-PDA测定各有关物质的紫外吸收，柱后添加乙腈辅助LC-MS/MS测定各有关物质的二级质谱，并进行解析。在所建立的条件下，法罗培南钠及其各有关物质分离良好，检测出5个有关物质，对其进行结构解析。结果显示，法罗培南钠原料药中的有关物质为其降解产物和聚合物。制剂中有关物质的种类和含量较原料药均有所增加，加热处理样品后有关物质含量显著增加。建立的LC-MS/MS法有效地分离分析了法罗培南钠及有关物质，为其质量控制和工艺优化提供参考。Abstract: An LC-MS/MS method was established for the identification of the related substances in faropenem sodium.HPLC separation was carried out on Lichrospher ODS-3 column(250 mm×4.6 mm,5 μm) by gradient elution with a mobile phase consisting of 0.2% ammonium acetate and 0.5% formic acid aqueous solution and pure acetonitrile.The results were obtained by PDA and post-column acetonitrile aided positive ESI-MS and tandem mass spectrometry.Good resolution of faropenem sodium and its main related substances was achieved.Five related substances in faropenem sodium were detected by LC-MS/MS .Compared with the bulk pharmaceutical,the number and contents of the impurities in the preparations increased,especially after stress test in solutions with an elevated temperature.The established method is effective in the separation and identification of the related substances in faropenem sodium and the results are useful for its quality control.
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Keywords:
- faropenem sodium /
- related substances /
- LC-MS/MS
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