《LC_MS_MS法对法罗培南钠中有关物质的研究》.pdfVIP

学报 342 Journal of China Pharmaceutical University 2011，42 (4):342 － 347 LC-MS / MS 法对法罗培南钠中有关物质的研究 * ＊＊ 秦 芳，丁 娅 ，杭太俊 ，宋 敏 (中国药科大学药物分析学教研室，南京210009) 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。 关键词 法罗培南钠;有关物质;LC-MS / MS 中图分类号 R917 文献标识码 A 文章编号 1000 － 5048 (2011)04 － 0342 － 06 Identification of the related substances in faropenem sodium by LC-MS / MS QIN Fang ，DING Ya* ，HANG Tai-jun ＊＊ ，SONG Min Dep artment of Pharmaceutical Analysis ，China Pharmaceutical University ，Nanj ing 210009 ，China 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 tan- dem 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 separati