目的 确定托吡酯有关物质检测条件及定量方法。方法 采用C18柱，流动相为乙腈–水（50∶50），柱温和检测器温度为55 ℃，体积流量为0.6 mL/min，采用示差折光检测器。测定托吡酯有关物质检测质量浓度4～40 mg/mL与峰面积的线性关系；并对检测方法进行验证。结果 托吡酯有关物质检测质量浓度在4～40 mg/mL，随着主成分质量浓度的提高，逐渐不呈线性关系；托吡酯在0.008～0.800 mg/mL与峰面积呈良好的线性关系，其相关系数为1.000 0；最低检测限为0.2 μg；重复性良好。结论 采用自身对照法比面积归一化法更准确可靠，更适宜于托吡酯的质量控制

Objective To improve the HPLC method for the determination of topiramate-related substances. Methods The HPLC column was Kromasil C18 , the mobile phase was acetonitrile-water (50:50), column and detector temperature were 55 ℃, the flow rate was 0.6 mL/min, and a differential refractive index detector was used. The linear relationship between topiramate-related substances in the range of 4—40 mg/mL and the peak area was detected and the detection methods were verified. Results With the content increasing, the linear relationship disappeared. As the linear range of topiramate was 0.008—0.800 mg/mL (r=1.000 0), there was a better linear relationship between them, for which the lowest detected limit of topiramate was 0.2 μg with a good repeatability. Conclusion It is more accurate and reliable using the self contrast method than the area normalization method in the quality control of topiramate.