HPLC法柱后衍生荧光测定伏格列波糖片有关物质及含量  

Test of Related Substances and Determination of Contents in Voglibose Tablets by HPLC Post Column Derivation with Fluorescence Detection

作　　者：张秀玲[1] 左文坚[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药品标准》2004年第5期41-43,共3页Drug Standards of China

摘　　要：目的:用高效液相色谱法柱后衍生荧光测定伏格列波糖片有关物质及含量。方法:以不同浓度的辛烷磺酸钠磷酸盐缓冲液(pH3.5)为流动相,检测波长:激发光波长350nm,发射光波长430nm,柱后衍生。调节流速使伏格列波糖峰保留时间约为20分钟时(有关物质),使伏格列波糖峰保留时间约11分钟时(含量测定),荧光试剂溶液的流速与流动相的流速相同,反应浴温度为100℃,冷却浴温度约为15℃。结果:本品有关物质测定时,主峰与杂质峰能较好的分离,含量测定回收率为100.2%,RSD=1.06%(n=6),重复性试验RSD=1.23%(n=6)。结论:该法快速简便,精密度高,分离效果好,结果准确。Objective:A HPLC post column derivation fluorescence detection method has been developed for the test of related substances and determination of contents in Voglibose Tablets. Methods: Using sodium octanesulfonate phosphate buffer solution as the mobile phase,the analysis was carried out on an ODS column. After derivated with fluorecence reagent at 100℃and then cooled at 15℃,the eluents were detected with fluoescence detector with excitation wavelength at 350nm and emission wavelength at 430nm. Results: Voglibose is linear at the concentration range from 18-90μg/ml(r = 0. 9986). The recovery is 100. 2%(RSD=1. 06%). Conclusions:The method has been proved to be fast,simple,accurate and effective.

关 键 词：有关物质 伏格列波糖 荧光测定 HPLC法 含量测定 RSD 保留时间 衍生 磺酸 重复性试验 

分 类 号：R927[医药卫生—药学] R587.1