Determination of Related Substances in Cefixime Tablets by HPLC
Objective:To establish a HPLC method for the determination of related substances in cefixime tablets.Methods:The analytical column was Welch XB C18(4.0 mm×125 mm,5 pm),mobile phase A was tetrabutylammonium hudroxide solution-acetontrile(75∶25,volume ratio),mobile phase B was acetonitrile,gradient elution.The column temperature was 40 ℃,the detective wavelength was 254 nm,and the flow rate was about 1.0 mL/min.Results:The method had good specificity,and the separation degree between cefixime and each impurity peak is fine.In the respective concentration range,the concentration of cefixime and 5 impurity solutions has a good linear relationship with the peak area(r ≥0.999 9).Quantitative limits,detection limits,durability,etc all meet the requirements.Conclusion:The method is simple,rapid and effective for the detection of related substances in cefixime tablets.
万方数据
维普
