Abstract：ObjectiveTo establish a HPLC method for the determination of related substances of Econazole Nitrate in Triamcinolone Acetonide Acetate and Econazole Nitrate Cream.MethodsThe ZORBAX Eclipse XDB-C18(4.6 mm× 100.0 mm,3.5 μm)column was adopted.The mobile phase consisted of a mixture of Methanol-0.077%solution of Ammonium Acetate (20:80)as mobile phase A,a mixture of Methanol-Acetonitrile (40:60)as mobile phase B,which was used as gradient elution.The detection wavelength was 225 nm.The flow rate was 1.0 ml/min,and the column temperature was 35℃.ResultsEconazole Nitrate was well separated from impurity.The calibration curves was linear in range of 0.2-100.0 μg/ml for Econazole Nitrate,the regression equation was y=15.6295x+4.5920 (r=0.999 97).ConclusionThis method is simple and feasible to determine the related substances of Econazole Nitrate in Triamcinolone Acetonide Acetate and Econazole Nitrate Cream.
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