RP-HPLC法测定万氏牛黄清心丸(浓缩丸)中盐酸小檗碱的含量  

Determination of the Content of Berberine Hydrochloride in Wanshi Niuhuang Qingxin Pill (Concentrated Pill)by RP-HPLC

作　　者：苏健俊[1] 丁野[1] 

机构地区：[1]湖南省药品检验所,长沙410001

出　　处：《中国药品标准》2005年第5期19-21,共3页Drug Standards of China

摘　　要：目的:建立万氏牛黄清心丸(浓缩丸)的含量测定方法,有效控制该制剂的质量。方法:采用RP-HPLC法测定盐酸小檗碱的含量。以乙腈-0.05mol/L磷酸二氢钾溶液(10%氢氧化钾调pH5.0)(28∶72)为流动相,PolarisC18-A(250mm×4.6mm,5μm)为色谱柱;265nm为检测波长。结果:测得线性范围0.0256～0.2304μg(r=0.9999),平均回收率为99.02%,RSD=1.61%(n=5)。结论:本方法可作为该制剂的质控指标。Objective：To establish a method of quantitative analysis of Wanshi Niuhuang Qingxin Pill （Concentrated Pill）by RP-HPLC. Method：To determine the content of berberine hydrochloride by RP-HPLC,using a column packed with Polaris C18-A（250mm × 4.6mm, 5μm）and a mixture of acetonitrile 0.05mol/L phosphate dihydropotassium solution（10% potassium hydroxide pH5. 0）（28 ： 72）as the mobile phase,detection wavelength is 265nm. Result：The linear range was 0. 0256-0. 2304 μg （r = 0. 9999）,the mean recovery of berberine hydrochlorde was 99.02 % ,RSD1.61% （n= 5）. Conclusion： The method is reliable.

关 键 词：RP-HPLC 万氏牛黄清心丸 盐酸小檗碱 RP-HPLC法测定 万氏牛黄清心丸 含量测定方法 盐酸小檗碱 浓缩丸 平均回收率 氢氧化钾 线性范围 检测波长 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]