目的 確定托吡酯有關(guān)物質(zhì)檢測條件及定量方法。方法 采用C18柱，流動相為乙腈–水（50∶50），柱溫和檢測器溫度為55 ℃，體積流量為0.6 mL/min，采用示差折光檢測器。測定托吡酯有關(guān)物質(zhì)檢測質(zhì)量濃度4～40 mg/mL與峰面積的線性關(guān)系；并對檢測方法進行驗證。結(jié)果 托吡酯有關(guān)物質(zhì)檢測質(zhì)量濃度在4～40 mg/mL，隨著主成分質(zhì)量濃度的提高，逐漸不呈線性關(guān)系；托吡酯在0.008～0.800 mg/mL與峰面積呈良好的線性關(guān)系，其相關(guān)系數(shù)為1.000 0；最低檢測限為0.2 μg；重復(fù)性良好。結(jié)論 采用自身對照法比面積歸一化法更準(zhǔn)確可靠，更適宜于托吡酯的質(zhì)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.