HPLC法测定消糖灵胶囊含量研究

Quantity Determination of Xiaotangling Capsules by HPLC

目的 :建立消糖灵胶囊的含量测定方法。方法 :采用高效液相色谱法。测定盐酸小檗碱 :用DiamonsilC18(2 5 0×4 .6mm ,5 μm)色谱术 ,乙腈—四氢呋喃—冰醋酸—水 (1 4 1 94 )为流动相 ,流速 1ml/min ,检测波长 345nm ,柱温 4 0℃。测定格列本脲 :参照《中华人民共和国药典》(二部 ) (2 0 0 0年版 )格列本脲项下有关方法。结果 :盐酸小檗碱线性范围为 0 .184～1.6 5 6 μg (r=0 .9995 ) ,平均回收率 10 0 .4 7% ,RSD =1.88% ;格列本脲线性范围为 2～ 12 μg (r =0 .9999) ,平均回收率 98.5 1% ,RSD =1.6 3%。结论 :该方法可用于消糖灵胶囊的质量控制。

Objective:To build the quantity determination method of Xiaotangling capsules.Methods:Determination of Hydrochloric Berberine with HPLC,Column: Diamonsil C 18(250×4.6mm, 5μm), mobile phase: acetonitrile- tetrahydrofuran- acetic acid - H 2O (14194),speed:2ml/min,detection wavelength:345nm, temperature:40℃; Determination of glibenclamide refering the related methods of China Pharmacopoeia (2000 edition). Results: the linear range of Hydrochloric berberine was 0.184～1.656μg(r=0.9995) and the average recovery was 100.47%(RSD1.88%); the linear range of glibenclamide was 0.184～1.656μg(r=0.9995) and the average recovery was 100.47%(RSD1.88%). Conclusion: This method could be applied in the quality control for Xiaotangling capsules.