梯度洗脱HPLC法测定硝酸益康唑的有关物质

Determination of related substances in econazole nitrate by gradient elution HPLC

目的:建立梯度洗脱HPLC法测定硝酸益康唑的有关物质。方法:采用Thermo Hypersil BDS C18(100mm×4.6mm,3μm)色谱柱,以甲醇-0.077%醋酸铵溶液(20:80)为流动相A,甲醇-乙腈(40:60)为流动相B,梯度洗脱,流速0.9mL.min-1,检测波长225nm,柱温35℃。结果:硝酸益康唑浓度在4.03～50.35μg.mL-1范围内,与峰面积呈良好的线性关系,r=0.9999。结论:本法简便、准确,可定量测定硝酸益康唑的有关物质。

Objective：To establish a gradient elution HPLC method to determine the related substances of econazole nitrate.Methods：Thermo Hypersil BDS C18（100 mm×4.6 mm,3 μm ） column was adopted.The mobile phase consisted of a mixture of methanol-0.77% solution of ammonium acetate（20：80） as mobile phase A,a mixture of methanol-acetonitrile（40：60） as mobile phase B.Gradient elution was used.The flow rate was 0.9 mL·min-1.The detection wavelength was 225 nm,and the column temperature was 35 ℃.Results：The calibration curves was linear in the range of 4.03-50.35 μg·mL-1 for econazole nitrate（r=0.9999）.Conclusion：This method is simple and accurate for determination of related substances in econazole nitrate.