HPLC-RID法测定托吡酯含量及主要有关物质  

HPLC-RID determination of topiramate and its main related substance

作　　者：王慧[1] 吴松[2] 戚燕[2] 郝玲花[2] 邓健[1] 

机构地区：[1]南华大学化学化工学院,衡阳421001 [2]中国医学科学院中国协和医科大学药物研究所,北京100050

出　　处：《药物分析杂志》2011年第2期266-269,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：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 calibration curves of it＇s main related substance were linear between 10-90 μg·mL-1（r=0.9999）.Intra-day and inter-day RSDs were 0.3%（n=6）,1.0%（n=6） and 1.0%（n=5）,1.0%（n=5）.Conclusion：The method was found to be simple,sensitive and can be applied to determine the major impurity of topiramate.

关 键 词：托吡酯 含量测定 有关物质 HPLC-RID 

分 类 号：R917[医药卫生—药物分析学]