HPLC法测定高乌甲素凝胶贴膏的含量及含量均匀度  

Determination the Content and Uniformity of Lappaconitine Cataplasm by HPLC

作　　者：李悦[1,2] 芦晓彤 韦悦[1,2] 楼炜[3] 李伟[1] 沈腾[2] 

机构地区：[1]山东中医药大学药学院,山东济南250355 [2]复旦大学药学院药剂学教研室智能化递药教育部重点实验室,上海201203 [3]浙江中医药大学附属第三医院,浙江杭州310005

出　　处：《现代中药研究与实践》2016年第5期62-64,71,共4页Research and Practice on Chinese Medicines

摘　　要：目的建立高乌甲素凝胶贴膏含量测定及含量均匀度检查的高效液相色谱法。方法采用Kromasil—C18（250mm×4．6mm，5μm）；以0．1mol／L磷酸二氢钠：甲醇（20：80）为流动相，并用磷酸调pH为4．2；检测波长为252nm；流速为1ml／min。结果在该色谱条件下，各杂质峰与主峰均能良好分离，浓度在0．5～50．0g/ml范围内与色谱峰面积呈线性关系（r=0．9999），平均加样回收率为99．2％。RSD为1．09％。3批高乌甲素凝胶贴膏的平均含量分别为101．27，100．44，99．94％。含量均匀度符合药典规定。结论本方法适用于高乌甲素凝胶贴膏的含量测定及含量均匀度的检查。Objective To establish an HPLC method for determination the content and uniformity of lappaconitine cataplasm. Methods Kromasil-C18 （250mm×4.6mm,5μm） column was used, and 0.1 mol/L NaH2PO4-methanol（20 ： 80） adjust to pH 4.2 with phosphoric acid, was taken as them mobile phase. The detection wavelength was 252 nm. The flow rate was 1 ml/min. Results In this method, the main can good separation with each impurity peak. The calibration curve was linear in the range of 0.5 - 50.0 μg/ml（r = 0.999 9）. The average sample recovery rate was 99.2 %, RSD = 1.09 %. The average content of three batches of lappaconitine cataplasm are 101.27%, 100.24%, 99.94%. Content uniformity conform to the requirement of pharmacopoeia. Conclusion The method can be used for determination the content and uniformity of lappaconitine in cataplasm.

关 键 词：高乌甲素 凝胶贴膏 高效液相色谱 含量 含量均匀度 

分 类 号：R927.2[医药卫生—药学]