HPLC法测定注射用头孢米诺钠的有关物质及含量

Determination of in related substances cefminox sodium for injection by HPLC

目的建立注射用头孢米诺钠的有关物质及含量测定方法。方法采用高效液相色谱法,色谱柱为Shimpack VP-ODS(4.6mm×250mm,5μm);流动相为醋酸溶液(取10mL冰醋酸,加水980mL)-甲醇-四氢呋喃(990∶5∶5)。检测波长为254nm;柱温25℃,进样量为20μL。结果含量平均回收率为99.8%,有关物质3批样品与市售品均符合规定。结论本文建立的方法,简便,重现性好,可用于注射用头孢米诺钠的有关物质及含量测定。

OBJECTIVE To establish a method for determination of related substances and their content in cefminox sodium.METHODS HPLC column was used with Shimpack VP-ODS(4.6mm ×250mm,5μm);mobile phase,acetic acid(10mL glacial acetic acid taken,add water,980mL)-methanol-tetrahydrofuran(990∶ 5∶ 5).The detection wavelength was 254nm;column temperature was 25℃,and the injection volume was 20μL.RESULTS The average recovery was 99.8%,The related substances in three batches of samples and commercial goods all met the requirements.CONCLUSION This method is simple,reproducible,and can be use for determination of related substances in cefminox sodium for injection.