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.
出处
《中国药品标准》
CAS
2005年第5期19-21,共3页
Drug Standards of China
