Objective To develop an HPLC method for determination of related substances in Flurbiprofen Gel Plaster by HPLC.Methods Agilent Zorbax XDB-C18 column(150 mm×4.6 mm,5 μm)was used,mobile phase A was acetic acid aqueous solution(5∶60),mobile phase B was acetonitrile,with gradient elution.The column temperature was 30℃,detection wavelength was set at 254 nm,flow rate was 1.0 mL/min,and injection volume was 20 μL.Determination of the degradation impurities flurbiprofen glycerol ester(impurity A)and flurbiprofen menthyl ester(impurity B)in Flurbiprofen Gel Plaster were calculate by principal component self-comparison method with a correction factor.Results The linear range of impurity A and B was 0.01-5.40 and 0.10-16.20 µg/mL.The average recovery was 98.9%and 97.9%,with RSD 1.0%and 2.2%.The results met the limit requirements.Conclusion The method is simple to operate,easy to obtain reagents,and has good reproducibility,and can effectively separate and quantify impurities A and B in Flurbiprofen Gel Plaster.
关键词
氟比洛芬凝胶贴膏/氟比洛芬/氟比洛芬甘油酯/氟比洛芬薄荷酯/高效液相色谱
Key words
Flurbiprofen Gel Plaster/flurbiprofen/flurbiprofen glycerol ester/flurbiprofen menthyl ester/HPLC
万方数据