HPLC-ELSD法测定普瑞巴林的光学纯度  

Enantiospecific Analysis of Pregabalin by HPLC-ELSD

作　　者：陈亮[1] 王国海[1] 陈建征[1] 刘秀英[1] 

机构地区：[1]江苏恩华药业股份有限公司技术中心,江苏徐州221007

出　　处：《福建分析测试》2009年第3期14-16,共3页Fujian Analysis & Testing

摘　　要：目的:建立高效液相色谱-蒸发光散射检测法(HPLC-ELSD)检测普瑞巴林的光学纯度。方法:选择ChiralcelOD-H色谱柱(250mm×4.6mm);以正己烷-异丙醇-三氟乙酸(965:32:3)为流动相;流速为0.5mL/min;采用蒸发光散射检测器,漂移管温度为80℃,载气流速为1.6L/min。结果:普瑞巴林的两种光学异构体(S/R)达到良好分离,R-异构体在1.013～10.13μg/mL范围内线性良好,r=0.99902,平均回收率为99.6%(n=15),检测限为12.3ng。结论:本文建立方法简单、快速、灵敏、准确、可靠,适用于普瑞巴林及制剂的光学纯度检测。Objective ：To establish an HPLC-ELSD method for the determination of optical parity of pregabalin. Methods：The chromatography was performed on a column of Chiralcel OD-H. （250mm×4.6mm）. The mobile phase was Hexane-isopropanol-trifluoroacetic acid （965：32：3） with the flow rate of 0.5mL/min. ELSD was used as the detector with the drift tube temperature of 80℃ ,and the flow rate of nebulizing gas was 1.6L/min. Results：The derivatives of S/P,- pregabalin were reasonably separated. The standard curve of R- pregabalin was linear within a range of 1.013 - 10.13 μg/mL. The average recovery, was 99.6% （n= 15） ,and the limit of determination was 12.3ng. Conclusions ：The alethod was simple, rapid, sensitive, accurate, repeatable and can be used for the control of pregabalin＇s optical purity.

关 键 词：普瑞巴林 光学异构体 高效液相色谱 蒸发光散射检测器 

分 类 号：R917[医药卫生—药物分析学]