HPLC测定雷诺嗪缓释片的含量及有关物质

Determination of related substance and content in Ranolazine-sustained release tablets by HPLC

目的采用HPLC测定雷诺嗪缓释片的含量和有关物质。方法采用Inertsil C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.02 mol·L-1磷酸二氢钾-三乙胺(52∶48∶0.1),流速1.0 mL·min-1,检测波长230 nm。结果雷诺嗪与中间体Ⅰ及其降解产物能有效分离,雷诺嗪20.24～506.00μg·mL-1与峰面积线性关系良好(r=0.9999,n=5),平均回收率为99.89%(RSD=0.61%,n=9),检测限为0.5 ng,中间体Ⅰ对雷诺嗪的相对保留时间约为0.25,相对响应因子约为1.25。结论所用方法简便、准确、重复性、专属性及灵敏度好,可用于雷诺嗪缓释片中有关物质和含量的测定。

OBJECTIVE To establish an HPLC method to determine the related substance and content in Ranolazine-sustained release tablets.METHODS Inertsil C18 column（250 mm×4.6 mm,5 μm）served as the solid phase,and acetonitrile-0.02 mol·L-1 potassium dihydrogen phosphate-triethylamine（52：48：0.1） was used as the mobile phase.The flow rate was 1.0 mL·min-1,and the detection wavelength was 230 nm.RESULTS Ranolazine and its related substance could be separated effectively.There was a good linear relationship between the peak area and the concentration in the range of 20.24-506.00 μg·mL-1（r=0.9999,n=5）.The average recovery was 99.89%（RSD=0.61%,n=9）,and the LOD was 0.5 ng.The relative retention time between intermediatesⅠ and ranolazine was about 0.25,and the relative response factors was about 1.25.CONCLUSION The method is simple,specific,sensitive and suitable for the determination of related substance and content in Ranolazine-sustained release tablets.