注射用头孢他啶的有关物质测定  

Determination of Related Substanses of Ceftazidime for Injection

作　　者：张冬[1] 郭毅[1] 孙卫 韩国将[3] 

机构地区：[1]河北省药品检验所,河北石家庄050011 [2]华北制药股份有限公司,河北石家庄050015 [3]长治医学院,山西长治046000

出　　处：《中国药业》2008年第13期34-36,共3页China Pharmaceuticals

摘　　要：目的建立注射用头孢他啶有关物质的检测方法。方法采用高效液相色谱(HPLC)法,色谱柱为Hypersil BDS C18柱(250mm×4.6mm,5μm),柱温35℃,流动相为磷酸二氢铵溶液(10%磷酸溶液调pH值至3.9)-乙腈(93∶7),检测波长为254nm。结果HPLC法可有效检出样品经破坏性试验处理后产生的杂质,主峰与杂质峰的分离度大于1.5,头孢他啶的最低检出限为0.2ng。结论HPLC法灵敏度高、专属性强,可作为注射用头孢他啶有关物质的法定分析方法。Objective To establish a HPLC method for the related substanses determination of eeftazidime for injection. Methods The BDS Hypersil C18 column （250 mm ×4. 6 mm,5 μm） was used. The temperature of column was 35 ℃. The mobile phase was ammonium dihydrogen phosphate solution （adjusted to pH 3.9 with 10% phosphoric acid solution）-acetonitrile （93：7）.The detection wavelength was 254nm. Results The sample was tested by high temperature, acid, oxidation and photolysis, and the resulted products were found increases of impurities. The main peak and the peaks of impurities could be separated efficiently by this method. The minimum detection limit for eeftazidime was 0. 2 ng. Conclusion This method is found to be sensitive. This method can be use as a standard quality control method of eeftazidime for injection.

关 键 词：注射用头孢他啶 有关物质 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学] R978.11