RP-HPLC梯度洗脱法测定盐酸伊托必利的有关物质

目的:建立RP-HPLC梯度洗脱法测定盐酸伊托必利的有关物质。方法:Alltima C18柱(4.6 mm×250 mm,5μm);流动相为0.05 mol.L-1磷酸二氢钾溶液(调节pH至4.0)-乙腈进行梯度洗脱,流速1.0 mL.min-1,柱温35℃,检测波长258nm,进样量20μL。结果:本文色谱条件中盐酸伊托必利与杂质有较好分离,盐酸伊托必利浓度在1～10μg.mL-1范围内与峰面积线性关系良好(r=0.9999,n=5),最低检测限为6 ng。结论:本法简便、专属,重复性好,可用于测定盐酸伊托必利的有关物质。

RP-HPLC determination of related substances of itopride hydrochloride

Objective:To establish an RP-HPLC method for determining the related substances of itopride hydrochloride.Methods:Alltima C18 column(4.6 mm×250 mm,5 μm) was adopted with the mobile phase consisting of 0.05 mol L-1 potassium dihydrogen phosphate(pH:4.0)-acetonitrile at the flow rate of 1.0 mL·min-1.The column temperature was 35 ℃.The UV detection wavelength was set at 258 nm.The injection volume was 20 μL.Results:Under the above conditions,itopride hydrochloride and its related substances were separated quite well.Itopride hydrochloride had a good linear relationship(r=0.9999,n=5) with the peak area within the range of 1-10 μg·mL-1.The minimal limit of detection was 6 ng.Conclusion:The method is simple and specific with great repeatability and can be used for determining the related substances of itopride hydrochloride.