Determination of Related Substances of Cefotaxime Sodium by HPLC
A detection method for related substances of cefotaxime sodium was established by using Agilent C18 column with pH=6.2 disodium hydrogen phosphate buffer-acetonitrile as the mobile phase.The detection wavelength was 235 nm,the column temperature was 30℃,the inlet room temperature was 4℃,the flow rate was 1.0 mL·min-1,and the injection volume was 10 μL.Accurate qualitative and quantitative analysis of cefotaxime sodium related substances was realized.The results showed that the detection limits for impurities A,B,C,D,E,F,G,H,7-ACA and J were 0.007 8,0.015 1,0.012 6,0.005 3,0.010 8,0.005 4,0.020 1,0.012 9,0.021 4,0.014 0 μg·mL-1,the limits of quantification were 0.026 6,0.051 4,0.043 0,0.018 8,0.035 9,0.018 0,0.067 4,0.043 1,0.071 5,0.047 2 μg·mL-1,the concentration linear range was 0.018 0～16.614 0 μg·mL-1,and the linear relationship was good,the correlation coefficient was≥0.999;the average recoveries were within the range of 90%～108%.The method has strong specificity,high sensitivity and good durability,which can meet the inspection requirements.
万方数据
维普
