HPLC法测定花蛇解痒片中盐酸小檗碱的含量

Determination of Berberine Hydrochloride in Huashe Jieyang Tablets by HPLC

建立HPLC法测定花蛇解痒片中盐酸小檗碱含量的方法。方法是采用十八烷基硅烷键合硅胶色谱柱 以乙腈：0.05mol.L-1磷酸二氢钠溶液（磷酸调pH值2.8）=28.5∶71.5为流动相,流速1.0ml.min-1,检测波长265nm,进样量10μl 柱温为室温。结果盐酸小檗碱进样量在0.0421-0.4208μg范围内呈良好的线性关系（r=0.9998）。精密度试验的RSD为0.33%,重复性试验的RSD为0.93%,加样回收试验的平均回收率为98.74%,RSD=1.19%（n=6）。该方法测定10批样品的盐酸小檗碱平均含量为每片0.39mg,与标准中拟定的0.3mg相近。该方法简便、可靠、准确,可用于该制剂的质量控制。

A method of determination for Huashe Jieyang tablets is given.Hypersil by HPLC is employed.ODS2 column,acetonitrile-0.05mol·L-1 potassium dihydrogen phosphate solution is employed and pH value was adjusted to 2.8 with phosphoric acid（28.5∶71.5） as mobile phase,the flow rate was 1.0 ml·min1 and 265nm as ultraviolet detection wavelength,column temperature is room temperature and injection volume is 10μl.The calibration curve of berberine hydrochloride showed a good linearity within the range of 0.0421～0.4208μg,r=0.9998.The average recovery was 98.74% and RSD was 1.12%（n=6）.The method is simple,rapid and specific with accurate and reliable results,which can be used to control the quality of products effectively.