摘要
[Objectives]To establish an LC-MS method for the determination of dibromoacetic acid in Cefathiamidine and Cefathiamidine for Injection.[Methods]Shiseido PC HILIC column(2.0 mm ×100 mm,3μ.m)was used.The mobile phase was 0.005 Mammonium formate and the mobile phase was acetonitrile with gradient elution.The flow rate was 0.3-0.8mL/min.[Results]The limit of detection was 0.2500 ng/mL and the limit of quantification was 0.500 ng/mL,which were 2.5%and 5.0%of the impurity limits,respectively.The recov-ery rate was 103.85%.[Conclusions]This method improved the detection of dibromoacetic acid impurities in Cefathiamidine,and has that advantage of good specificity,low limit of detection and limit of quantification,high sensitivity,high accuracy,interference resistance,can meet the detection requirements of Cefathiamidine,and is suitable for the quality control of Cefathiamidine.
基金
Supported by Central Fund for Guiding Local Science and Technology Develop-ment(ZY20230102)
Guilin Scientific Research and Technology Development Plan Project(20220104-4).
