期刊论文

中文

药物分析杂志

0254-1793

2011

31

2

266-269

10.16155/j.0254-1793.2011.02.030

本校为第一机构

目的:建立托吡酯含量测定及有关物质检查的方法.方法:采用Phenomenex Luna C8柱(250 mm×4.6 mm,5μm),柱温35℃,光学元件温度:35℃;流动相为乙腈-0.01 mol. L-1醋酸铵溶液(用醋酸调节pH为4.2)(1:2),流速为1.0 mL.min-1,示差折光检测器.结果:高效液相色谱法测定的线性范围为:托吡酯5~15 mg.mL-1,相关系数r=0.9999;杂质10~90μg.mL-1,相关系数r=0.9999;日内精密度:托吡酯RSD为0.3%(n=6),杂质RSD为1.0%(n=6);日间精密度:托吡酯RSD为1.0%(n=5),杂质RSD为1.0%(n=5).结论:方法简单,灵敏度较好,可用于托吡酯的含量检测和主要杂质的研究

Objective：To establish an HPLC-RID method for the determination of topiramate and its related substance.Method：The separation was performed on a Phenomenex Luna C8 column（250 mm×4.6 mm,5 μm）,and the column temperature was 35 ℃.The mobile phase consist of acetonitrile-0.01 mol·L-1 ammonium acetate solution（adjusted to pH 4.2 with acetic acid）（1∶2）,the flow rate was 1.0 mL·min-1,using the differential refractive index detector.Results：The calibration curves of topiramate were linear between 5-15 mg·mL-1（r=0.9999）,and the calibra...