Objective This study improved the determination method of related substances in cefoxitin sodium for injection.Methods The column of phenyl silane-bonded silica gel as filler(Inertsil Ph-3,4.6 mm×250 mm,3 μm)was used,and the mobile phase was composed of mobile phase A(1.0 g/L solution of ammonium formate adjusted to pH 2.7 with formic acid)and mobile phase B(acetonitrile)to carry out gradient elution.The flow rate was 1.0 mL/min.The column temperature was 35 ℃ and the detection wavelength was 254 nm.Results The peaks of cefoxitin sodium and its related substances were separated well.The linearity was good within the range of 0.0446～13.3692 μg/mL,and the limit of detection was 0.89 ng.Precision and repeatability met the requirements.Conclusion The method had the advantages of high sensitivity and good resolution,and could be used for the simultaneous detection of impurities and polymers.
关键词
注射用头孢西丁钠/有关物质/聚合物/方法优化/质量控制
Key words
Cefoxitin sodium for injection/Related substances/Polymers/Method optimization/Quality control
维普
万方数据