高效液相色谱法测定雷西纳德原料药的含量

Determination of Content in Lesinurad by HPLC

建立了高效液相色谱法测定雷西纳德原料药的含量。色谱柱为Luna C18(2)100A(150×4.6 mm,5μm);以甲醇-2%冰醋酸溶液(60:40)为流动相;流速1.0 ml•min^(-1),检测波长为290 nm。雷西纳德在浓度为10.19~50.94μg•ml^(-1)范围内与峰面积的线性关系良好(r=0.9998,n=5),平均回收率为99.68%(RSD为0.62%,n=9),8h溶液稳定性试验的RSD为0.46%,重复性试验的RSD为0.51%(n=6),雷西纳德和相邻峰之间的分离度良好。经方法学验证,该法适用于雷西纳德原料药的含量测定。

To establish an HPLC method to determine the content of Lesinurad.The analysis was achieved on a Luna C18(2)100A column(150×4.6mm,5μm),and used a mobile phase of methanol and 2%glacial acetic acid solution(60:40).The flow rate was 1.0 ml·min^(-1,)and the detection wavelength was 290nm.There was a good linear relationship between the peak area and the concentration in the range of 10.19~50.94μg•ml^(-1)(r=0.9998,n=5),the mean recovery was 99.68%(RSD=0.62%,n=9),the RSD of the 8h stability test was 0.46%,the RSD of the repeatability test was 0.51%,the resolution between Lesinurad and its adjacent peaks was achieved.The method of validation showed that it can be used for the determination of content of Lesinurad.