MEKC与HPLC测定头孢菌素有关物质的互补性分析  

Complementary MEKC and HPLC analysis for the related substances of cephalosporin

作　　者：李萍[1,2] 李娅萍[1] 邸欣[2] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]沈阳药科大学,沈阳110016

出　　处：《药物分析杂志》2011年第3期428-432,共5页Chinese Journal of Pharmaceutical Analysis

基　　金："十一五"国家科技支撑计划重点项目"我国当前急需建立和提高的药品监督检验技术研究"课题(2008BAI55B04)

摘　　要：目的:探索利用胶束毛细管电泳(MEKC)与高效液相色谱法(HPLC)分析原理的互补性,评价HPLC系统有效性的方法。方法:利用加速降解实验,比较HPLC和MEKC分析头孢地嗪钠和头孢米诺钠降解杂质的能力。结果:头孢地嗪钠和头孢米诺钠的MEKC和HPLC结果具有互补性。MEKC具有较强的杂质分离能力,但其检测限(LOD)较高。实际应用中,借助于加速实验,将MEKC分离出的杂质峰数目与HPLC分离出的含量大于MEKC LOD的杂质峰数目进行比较,当两者基本相对时,可以认为HPLC方法具有较满意的分离能力。结论:MEKC为评价HPLC方法的有效性提供了新的手段。Objective： To explore the principle complementarity of the MEKC and HPLC and the method in order to estimate the effectiveness of the HPLC system.Method：We analyze the degradative impurities produced by the cefodizime sodium and cefminox sodium and compare the procession in HPLC and MEKC.Result：We find that there is complementarity in the results of cefodizime sodium and cefminox sodium by the MEKC and HPLC.But we can isolate the impurities easily by the MEKC and the LOD is higher than by the HPLC.When the amount of impurities by the MEKC and HPLC is same,we think that HPLC is suitable to be applied.Conclusion：MEKC is a new means which can evaluate the effectiveness of the HPLC.

关 键 词：胶束毛细管电泳 高效液相色谱 头孢地嗪钠 头孢米诺钠 有关物质 

分 类 号：R917[医药卫生—药物分析学]