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头孢噻肟是HoechstMarionRoussel公司开发,1981年上市的第一个第三代头孢菌素,它对革兰氏阳性和革兰氏阴性菌均有较强的抗菌活性。按照中国药典95版规定采用生物效价法测定其含量,但该法费时繁琐,且由于不能分离杂质后进行含量测定,造成一定的假单位现象,精密度不如液相色谱法高。本文参照欧州药典第3版,应用高效液相色谱法对头孢噻肟含量及副产物进行分离测定,简便,快速,消除其副产物杂质所带来的影响。
Cefotaxime is the first third-generation cephalosporin developed by Hoechst Marion Roussel Company and marketed in 1981. It has strong antibacterial activity against Gram-positive and Gram-negative bacteria. In accordance with the provisions of the Chinese Pharmacopoeia 95 edition using biological potency method to determine its content, but the method time-consuming cumbersome, and because the impurities can not be separated after the determination of content, resulting in a certain phenomenon of false units, the precision is not as high as liquid chromatography. In this paper, the third edition of the European Pharmacopoeia, the application of high performance liquid chromatography for cefotaxime content and by-product separation and determination, simple, rapid and eliminate the by-product impurities impact.