注射用头孢哌酮钠舒巴坦钠中头孢哌酮杂质C的含量测定

摘要

Objective To establish a HPLC method for the determination of cefoperazone impurity C in cefoperazone sodium and sulbactam sodium for injection. Methods The analytes were analyzed on a C18 column, using a mixture of 0.005mol/L tetrabutylammonium hydroxide solution-acetonitrile (75: 25) as the mobile phase with a flow rate of l.OmL/min. Detection wavelength was 220nm, and the column temperature was maintained at 30℃. Results Cefoperazone impurity C was well separated from other impurities and both of cefoperazone and sulbactam were completely separated from their related substances. The calibration curve was linear in the range of 3.19-25.6ug/mL and the correlation coefficient was 0.9998. The average recovery was 97.45% and the RSD was 2.4% (n=9). Conclusion The established method is accurate, sensitive and specific. It is suitable to determinate cefoperazone impurity C in cefoperazone sodium and sulbactam sodium for injection and can be effectively used for quality control of the drug.%目的 建立HPLC外标法测定注射用头孢哌酮钠舒巴坦钠中的头孢哌酮杂质C.方法 使用C18色谱柱,以0.005mol/L氢氧化四丁基铵溶液-乙腈(75:25)为流动相,流速1.0mL/min,检测波长220nm,柱温为30℃.结果 头孢哌酮杂质C与相邻杂质、主成分与有关物质间达基线分离,头孢哌酮杂质C在3.19～25.6μg/mL范围内线性关系良好,其相关系数r=0.9998,平均回收率为97.45％,RSD为2.4％0=9).结论 所建立的方法准确、灵敏、专属性强,可用于测定制剂中头孢哌酮杂质C的含量,更有效的控制药品质量.