梯度洗脱HPLC法测定硝酸益康唑的有关物质___

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(100 mm×4.6 mm,3 μm)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0.9 mL·min^-1,检测波长225 nm,柱温35 ℃。 结果: 硝酸益康唑浓度在4.03~50.35 μg·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.