高效液相色谱法测定头孢克肟中间体

制药工程论文编号:ZY043    论文字数:7058,页数:25
目  录
中文摘要............................................................I
英文摘要...........................................................II
目录..............................................................III
1. 绪论.............................................................1
 1.1  头孢克肟在国内的发展.......................................1
 1.2  头孢克肟的特点.............................................2
 1.3  头孢克肟的合成路线.........................................3
2. 实验部分.........................................................5
 2.1  试剂和仪器.................................................5
 2.2  实验方法...................................................5
 2.3.4头孢克肟湿精品（M4-AP004）质量标准和检验操作规程.......8
3. 结果与讨论.......................................................9
 3.1 缩合液AVNA残留量的检测结果及分析............................9
 3.2 头孢克肟甲酯残留量检测结果及分析...........................13
 3.3 头孢克肟湿精品测定的结果及分析.............................16
 3.4 讨论.......................................................18
4. 总结与展望......................................................19
致谢...............................................................20
参考文献...........................................................21

摘要：本论文主要研究高效液相色谱法（HPLC）测定头孢克肟中间体AVNA (头孢克肟母核7-氨基-3-乙烯基-头孢烷酸)残留、头孢克肟甲酯残留和头孢克肟湿精品的含量，并简单介绍了高效液相色谱法的原理和操作规程。按照标准的操作规程，采用高效液相色谱法测得中间体的含量，判断中间体含量是否在标准范围之内，并分析各个中间体的含量是否符合生产要求。高效液相色谱法采用C18 柱(4.6mm×150 mm),以四丁基氢氧化铵溶液-乙腈(80：20，pH=7.0)为流动相;检测波长为254 nm，流速1.0ml/min。结果表明，该法能有效检测头孢克肟的中间体，具有柱效高、经济等优点，可用于头孢克肟反应过程的监测。
关键词：头孢克肟；高效液相色谱法；中间体

Abstract: In this thesis, high performance liquid chromatography (HPLC) is used to determine the intermediate AVNA of cefixime residue, methyl cefixime residue ,cefixime wet content . Also,the principle of HPLC and operating rules is introduced in the thesis. Under standard operating procedures, content of cefixime intermediates was detected by HPLC to determine whether the intermediates content was within the standard range and to analyse whether the content of the various intermediates accorded with production requirements. The HPLC system used C18 column (4.6mm×150mm), with the liquid phase tetrabutyl ammonium hydroxide solution-acetonitrile(80：20，pH=7.0) .The detection wavelength was 254 nm and the rate was 1.0ml/min. The results show that the method can detect the content of cefixime intermediates effectively and economically. This HPLC method can be used to monitor the cefixime reaction process.
关键词 头孢克肟；高效液相色谱鉴别法；头孢克肟母核7-氨基-3-乙烯基-头孢烷酸（ AVNA ）；头孢克肟甲酯；头孢克肟湿精品。Keywords：Cefixime; High performance liquid chromatography; Intermediates