HPLC法测定注射用头孢呋辛钠含量

HPLC determination of Cefuroxime sodium for injection

目的建立高效液相色谱法测定注射用头孢呋辛钠的含量。方法以十八烷基硅烷键合硅胶为填充剂,以pH 3.4的缓冲溶液-乙腈(86∶14)为流动相;检测波长为254nm;流速为1.0mL/min;进样量为20μL;柱温25℃。头孢呋辛峰与氨基甲酰头孢呋辛峰的分离度应不小于2.0。结果头孢呋辛钠在0.25～0.75g/L范围内,浓度与峰面积呈良好的线性关系,线性方程为:Y=19 730 707 X+874 894,r=0.9 991。结论该方法简便、快速、准确,适用于注射用头孢呋辛钠的含量测定。

Objective To establish a method of the content determination to Cefuroxime sodium for injection by HPLC.Methods The polar C18 was used as analysis column packed with octadecyl silane bonded silicagel with acetonitrile（86∶14） buffer as mobile phase（pH3.4）.The detection was processed in 254 nm of wave length with a flow rate of 1.0 ml/min,injection volume of 20 μL and column temperature at 25 ℃.The separation peak level for Cefuroxime and Amino formex cefuroxime should not be less than 2.0.Results Concentration and peak area showed a good linearity in the range of 0.25-0.75 g/L and linear equation Y=19 730 707X＋874 894（r=0.9 991）.Conclusion This method was simple,rapid,accurate,which can be used for the quality control of Cefuroxime sodium for injection.