Establishment of an HPLC method for determination of related substance of cefazoxime sodium for injection
Objective This study constructed an HPLC method for the determination of the related substance cefazoxime sodium for injection and analyzed the impurities in domestic products.Methods The HPLC analysis was performed on an Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5µm)with the column temperature at 35 ℃.The mobile phase A was the pH 3.6 ammonium acetate solution,and the mobile phase B was acetonitrile.Gradient elution was performed as follows:0→10 min,97％A→90％A;10→20 min,90％A→80％A;20→30 min,80％A;30→35 min,80％A→15％A;35→45 min,15％A;45→46min,15％A→97％A;46→55min,97％A.The flow rate was 0.8 mL/min.The detection wavelength was 254 nm.The injection volume was 20 μL.Results The acid,alkali,oxidation,high temperature,and light-forced degradation tests demonstrated good specificity of the methods.The linear range of cefzoloxime and cefazoxime was found to be between 0.75～4.5 μg/mL with a good linear relationship.The quantification limits of cefotaxime and 10 of the known impurities(impurity 18,open ring decarboxylated S-oxidel,open ring decarboxylated S-oxide2,impurity KTO,cefzoloxime open ring,impurity D,impurity 3,cefzoloxime E isomer,dimer and impurity 12)were 1.63,6.30,2.78,2.84,2.31,7.86,3.06,1.62,1.90,3.87 and 3.09 ng,respectively.The average recoveries of all known impurities were between 96.5％and 101.6％.The RSD of repeatability all met the requirements.Conclusion The method proved to be specific,accurate and rugged,which made it suitable for the related substance analysis of cefazoxime sodium for injection.It could be used for the control of cefazoxime sodium for injection in the domestic market.
万方数据
维普
