区带毛细管电泳法测定原料及其缓释胶囊中坦索罗辛  

Determination of tamsulosin and the intermediates in its raw material drug and sustained release capsules by capillary zone electrophoresis

作　　者：高苏亚[1,2] 李华[2] 刘常军[1] 张航[1] 程芳[1] 王冰[1] 

机构地区：[1]西安医学院药学院,西安710021 [2]西北大学分析科学研究所,西安710069

出　　处：《分析试验室》2014年第2期158-161,共4页Chinese Journal of Analysis Laboratory

基　　金：国家自然科学基金资助项目(20975081);西安医学院大学生科研计划项目(12DXS04)资助

摘　　要：建立了区带毛细管电泳法分离测定原料药及其缓释胶囊中坦索罗辛和有关中间体的方法。采用未涂层石英毛细管（75μmi．d．×60cm，有效长度50em），以20mmol／L硼砂（pH7．30）为运行缓冲液，检测波长230nm，阳极端压力自动进样10s（3．4kPa），分离电压15kV，温度25℃。坦索罗辛及其中间体在7min中内得以基线分离，坦索罗辛在10．28—123．4Ixg／mL（r=0．9995），（R）-5-（2-氨基丙基）-2-甲氧苯基磺酰胺在14．99—179．9μg／mL（r=0．9993），2-（2-乙氧苯氧基）溴乙烷在8．496—101．9μg／mL（r=0．9987）范围内线性关系良好，平均回收率分别为100．9％，100．1％和99．2％，平均RSD≤2．9％。方法为坦索罗辛缓释胶囊的测定和监测其合成生产过程提供了分析手段。A high performance capillary zone electrophoresis method was established for the determination of tamsulosin and the related substances in its bulk drug and sustained release capsules. An uncoated fused-silica capillary （75 μm i. d. ×60 cm, effective length 50cm） was used, with 20 mmol/L borate solution （pH7.30） as running buffer at the detection wavelength of 230nm. And the injection volume of sample was kept for 10 s at 3.4kPa. The separation voltage was set 15kV at 25 ℃. Tamsulosin and the related substances were separated well within 7 min. The calibration curves for tamsulosin, （R） -5 - （2-aminopropyl） -2- methoxybenzenesulsonamide and 2 - （2-ethoxyphenoxy） ethyl bromide were good linear in the range of 10. 28 ~ 123.4 μg/mL （r =0. 9995）, 14.99 ~ 179.9μg/mL （r =0. 9993） and 8.496 - 101.9 μg/mL （r =0. 9987）, respectively. Their average recoveries were 100. 9%, 100. 1% and 99. 2% , respectively. And their relative standard deviations （RSD） were all less than 2.9%. The method is proved to be specific, fast, accurate, cheap. and convenient. So the proposed CZE method can be used for determining tamsulosin and related substances in its sustained release capsules. It will also be a reliable way to monitor for synthesis process of tamsulosin.

关 键 词：坦索罗辛 缓释胶囊 区带毛细管电泳法 测定 

分 类 号：O657.8[理学—分析化学]