采用化学法分离得到头孢唑林钠中的杂质噻二唑,用薄层色谱(TLC)和高效液相色谱(HPLC)对分离得到的噻二唑样品初步定性,用红外吸收光谱(IR)对分离得到的噻二唑样品进行结构确认;根据相对保留时间确定其在头孢唑林钠中的残留;依据欧洲药典的方法,用质量分数为1.0 %的头孢唑林钠溶液做对照,以头孢唑林钠供试品溶液中噻二唑的峰面积与质量分数为1.0 %的对照溶液中头孢唑林钠的峰面积比计算噻二唑的含量.结果表明,分离得到的噻二唑是生产工艺过程的残留,所建立的方法适合头孢唑林钠中残留的噻二唑的定性定量分析.进行实际样品分析,其含量在安全限度范围内(质量分数不超过1.0 %),患者可以放心使用.

The impurity thiadiazole was separated from cefazolin sodium by chemical method, and the separated thiadiazole was identified using thin layer chromatography(TLC), high performance liquid chromatography(HPLC) and infrared absorption spectroscopy(IR) method;The residue of thiadiazole in cefazolin sodium was detected according to the relative retention time;The content of thiadiazole in cefazolin sodium was calculated through peak area ratio between its area in test solution and cefazolin sodium area in 1.0 % reference solution according to European Pharmacopoeia.The results shown that the separated thiadiazole was residual raw material. The proposed method was suitable for the qualitative and quantitative analysis of the residual thiadiazole in cefazolin sodium.The method has been applied to the determination of thiadiazole in several samples and the results show that the contents comply with security specification(not more than 1.0 %).