注射用头孢他啶/舒巴坦钠含量及有关物质测定方法研究  

RP-HPLC determination of two components and related substances in ceftazidime and sulbactam sodium for injection

作　　者：黄莉[1] 

机构地区：[1]武汉大学药学院,武汉430072

出　　处：《中国抗生素杂志》2005年第10期588-590,616,共4页Chinese Journal of Antibiotics

摘　　要：目的用RP-HPLC法测定注射用头孢他啶/舒巴坦钠中头孢他啶和舒巴坦的含量及其有关物质.方法用ZorbaxSB-C18色谱柱(250mm×4.6mm,5μm);乙腈:[(0.03mol/L磷酸二氢钾溶液:10%四甲基氢氧化铵溶液(795:15),磷酸调pH值为4.0](9:91)为流动相,检测波长230nm,流速1ml/min,进样量10μl,柱温30℃.结果头孢他啶与舒巴坦分别与其相邻杂质峰能完全分离,头孢他啶在18.07～3614.88μg/ml和舒巴坦在73.15～1755.53μg/ml浓度范围内线性关系良好(r=1.0000).结论该法简便、准确、专属性好,可以用于注射用头孢他啶/舒巴坦钠中头孢他啶和舒巴坦的含量测定及有关物质检查.Objective To establish an RP-HPLC method for the content determination of ceftazidime and sulbactam sodium and its related substances in ceftazidime and sulbactam sodium for injection. Methods The HPLC system consisted of a Zorbax SB-C18 column （250min×4.6ram, 5μm） and a mixture of acetonitrile[0. 03mol/L potassium dihydrogen phosphate solution and 10% tetrametyl ammonium hydroxide （795 ： 15）-] （9 ： 91） as mobile phase. The flow rate was 1.0ml/min with detection wavelength at 230nm and column temperature at 30℃. Results Ceftazidime and sulbactam could be completely separated from other impurities. The linear range of ceftazidime was 18.07～3614.88μg/ml and sulbactam was 73.15～1755.53μg/ml （both r= 1. 0000）. Conclusion The method is simple, accurate and suitable for the content determination of ceftazidime, sulbactam and related substances in ceftazidime and sulbactam sodium for injection.

关 键 词：头孢他啶 舒巴坦钠 有关物质 高效液相色谱法 

分 类 号：R978.11[医药卫生—药品]