强力天麻杜仲胶囊中乌头类生物碱成分的含量测定

Determination of Aconitine Alkaloids in Qiangli Tianmaduzhong Capsules by RP-HPLC

目的建立反相高效液相色谱(RP-HPLC)法测定强力天麻杜仲胶囊中新乌头碱和次乌头碱的含量。方法色谱柱为Agilent Zorbax Stable BondC18柱(4.6mm×250mm,5μm),流动相为用磷酸调pH=3的0.04mol/L三乙胺-乙腈(65∶35),流速1.0mL/min,检测波长235nm。结果新乌头碱、次乌头碱能良好分离,进样量分别在0.0468～1.17μg和0.0506～1.265μg范围内与峰面积线性关系良好,平均回收率分别为98.94%和98.98%,RSD分别为1.70%和1.56%(n=6)。结论方法简便、精确、专属性强,可作为强力天麻杜仲胶囊中乌头碱类成分的质量控制方法。

Objective To estahlish a RP-HPLC method of determining mesaconitine, hypaconitine in Qiangli Tianmaduzhong Capsules. Methods RP-HPLC was applied to determine mesaconitine, hypaconitine in Qiangli Tianmaduzhong Capsules. HPLC conditions were as follows： Agilent Zorbax StableBond C18 column （250 mm ×4.6 mm, 5 μm） was used, with acetonitrile-0. 04 mol/L triethylamine adjusting pH=3 with H3PO4（65 ： 35） as the mobile phase. The flow rate was 1.0 mL/min. The detection wavelenth was set at 235 nm. Resuits mesaconitine, hypaconitine derivatives were separated well. The linear range for mesaconitine and hypaconitine were 0. 046 8 - 1.17μg and 0. 050 6 - 1. 265 μg, respectively. Their average recovery rates were 98.94% with RSD of 1.70% and 98.98% with RSD of 1.56%, respectively. Conclusion The method is simple and accurate with strong specificity. It can be used to control the quality of mesaconitine, hypaconitine in Qiangli Tianmaduzhong Capsules.