RP-HPLC梯度洗脱法测定盐酸伊托必利的有关物质  

RP-HPLC determination of related substances of itopride hydrochloride

作　　者：李美芳[1,2] 刘敏[2] 王晓冲[2] 李军[2] 郭兴杰[1] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]深圳市药品检验所,深圳518027

出　　处：《药物分析杂志》2012年第8期1453-1456,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：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。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.

关 键 词：盐酸伊托必利 梯度洗脱 有关物质 高效液相色谱 质量控制 

分 类 号：R917[医药卫生—药物分析学]