Determination of Related Substances in Cefminox Sodium for Injection by HPLC
Objective:To establish a HPLC method for the determination of related substances in cefminox sodium for Injection.Methods:The analytical column was Inertsil Ph-3(4.6 mm×250 mm,3 μm);Mobile phase a was ammonium formate solution with pH 2.5,mobile phase B was acetonitrile,gradient elution.The column temperature was 35 ℃,the detective wavelength was 254nm,and the flow rate was about 1.0 mL/min.Results:The related impurities and the main components can be effectively separated in this method,cefminox and 12 kinds of impurities within their respective concentration and peak area show a good linearity(r≥0.999);The average recovery rate is in 95.0％～105.0％,RSD(n=9)＜3.0％;The limit of quantification,detection limit,durability,etc.all meet the requirements.Conclusion:The method is specificity,sensitive,and accurate for the determination of related substances,and it can effectively detect 12 kinds of impurities in cefminore sodium for injection;Compared with cefminore sodium for injection contained in import registration standard or Chinese pharmacopoeia,this method has stronger detection ability of various impurities,suitable for the detection of related substances in cefminol for injection.
cefminox sodium for injectionthe related substancesHPLC
万方数据
维普
