CAJ | 학술논문

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Chiralcel OD-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.
목적:건립고효액상색보-증발광산사검측법(HPLC-ELSD)검측보서파림적광학순도. 방법:선택Chiralcel OD-H색보주(250mm×4.6mm);이정기완-이병순-삼불을산(965:32:3)위류동상;류속위0.5mL/min;채용증발광산사검측기,표이관온도위80℃,재기류속위1.6L/min.결과:보서파림적량충광학이구체(S/R)체도량호분리,R-이구체재1.013～10.13μg/mL범위내선성량호,r=0.99902,평균회수솔위99.6%(n=15),검측한위12.3ng.결론:본문건립방법간단、쾌속、령민、준학、가고,괄용우보서파림급제제적광학순도검측.
Objective:To establish an HPLC-ELSD method for the determination of pregabalin's optical purity. 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/R pregabalin were reasonable separation of them. The standard curve of R- pregabalin was linear within a range of 1.013～10.13μg/mL. The average recovery was 99.6%(n=15) ,and the limit of determination was 12.3ng. Conclusions:The method was simple, rapid, sensitive, accuracy , repeatabile and can be used for the control of pregabalin's optical purity.