HPLC测定牛磺熊去氧胆酸胶囊中的有关物质  

Determination of related substances in Tauroursodeoxycholic acid capsule by HPLC

作　　者：张晓艳[1] 崔蕊[1] 贾建静[1] 刘利军[1] 张丹[1] 

机构地区：[1]四川大学华西药学院,四川成都610041

出　　处：《华西药学杂志》2012年第5期585-587,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用RP-HPLC法测定牛磺熊去氧胆酸胶囊中的有关物质。方法采用Diamonsil C18色谱柱(150 mm×4.6mm,5μm),流动相为0.02 mol.L-1磷酸二氢钠-乙腈(60∶40,磷酸调pH5.5),检测波长为205 nm,流速为1.0 mL.min-1,柱温30℃。结果牛磺熊去氧胆酸0.9694～96.94μg.mL-1与峰面积的线性关系良好(r=0.9999),检测限为0.3635 ng,定量限为1.454 ng。牛磺鹅去氧胆酸0.9443～94.43μg.mL-1与峰面积的线性关系良好(r=0.9999),检测限为9.447 ng,定量限为23.62 ng,方法回收率为99.54%。结论所用方法准确、灵敏、快速,适用于牛磺熊去氧胆酸胶囊中微量杂质的控制。OBJECTIVE To establish an RP-HPLC method for the determination of related substances in Tauroursodeoxycholic acid capsule.METHODS Analysis was carried out on a Diamonsil C18 column（150 mm×4.6 mm,5 μm） using phosphate buffer（0.02 mol·L-1 NaH2PO4）-acetonitrile（60：40）（adjusting pH to 5.5 with phosphoric acid） as mobile phase at detective wavelength of 205 nm.The flow rate was 1.0 mL·min-1 and the temperature was 30 ℃.RESULTS The linear range of Tauroursodeoxycholic acid was 0.9694-96.94 μg·mL-1（r=0.9999）,and the detection limit was 0.3635 ng with the lower limit of quantitation of 1.454 ng.The linear range of Taurochenodeoxycholic acid was 0.9443-94.43 μg·mL-1（r=0.9999）,and the detection limit was 9.447 ng with the lower limit of quantitation of 23.62 ng.The method recovery was 99.54%.CONCLUSION The method is accurate,sensitive and rapid for quality control of trace impurities in Tauroursodeoxycholic acid capsule.

关 键 词：高效液相色谱法 牛磺熊去氧胆酸胶囊 牛磺鹅去氧胆酸 有关物质 

分 类 号：R917[医药卫生—药物分析学]