心可宁胶囊中华蟾酥毒基和酯蟾毒配基的HPLC法含量测定  

Study on Determination of Cinobufagin and Resibufogenin in Xinkening Capsules by HPLC

作　　者：郭增光 罗晓倩 王丽娟 陈仁燕 

机构地区：[1]翔宇药业股份有限公司,临沂276023

出　　处：《中国药品标准》2017年第6期435-438,共4页Drug Standards of China

摘　　要：目的:建立HPLC法测定心可宁胶囊中华蟾酥毒基和酯蟾毒配基的含量测定方法,以更好的控制其质量。方法:采用Thermo C_(18)色谱柱,以0.5%磷酸二氢钾溶液-乙腈(50∶50)为流动相,用磷酸调pH至3.2,检测波长为296 nm。结果:华蟾酥毒基在30.72~71.68μg·mL^(-1)范围内呈良好的线性关系(r=1.0000),酯蟾毒配基在30.78~71.82μg·mL^(-1)范围内呈良好的线性关系(r=0.9999),华蟾酥毒基和酯蟾毒配基平均回收率分别为99.76%和99.88%,RSD分别为1.29%和0.62%;测定3批样品,华蟾酥毒基和酯蟾毒配基总量分别为0.053、0.053、0.054 mg·粒^(-1),RSD为1.09%。结论:本方法准确、有效,可以作为该类产品的质控检测方法。Objective： A HPLC method for the determination of cinobufagin and resibufogenin in Xinkening capsules was established to control the drug quality. Methods： The determination was carried out using an Thermo C18 column with a solvent system： 0.5% monopotassium phosphate-acetonitrile （50：50）. PH was adjusted to 3.2 with phosphoric acid and the detection wavelength was 296 nm. Results： The linear ranges of cinobufagin was 30.72～71.68 μg/mL （r=1） and the linear ranges of resibufogenin was 30.78～71.82 μg/mL （r=0.9999）. The average recovery of venenum bufonis was 99.43% and the RSD was 0.78%. Conclusion： It showed that this method was accurate and effective, and could be used as a quality control method.

关 键 词：心可宁胶囊 HPLC 华蟾酥毒基 酯蟾毒配基 

分 类 号：R921.2[医药卫生—药学]