HPLC法测定虎黄烧伤搽剂中盐酸小檗碱的含量

Content Determination of Berberine Hydrochloride in HuHuang Burn Liniment by HPLC

目的建立以高效液相色谱法测定虎黄烧伤搽剂中盐酸小檗碱含量的方法。方法采用高效液相色谱法,以盐酸小檗碱为对照品,色谱柱为ZORBAX Eclipse Plus C18(250mm×4.6mm,5μm),流动相为乙腈-0.05mol·L^-1磷酸二氢钾溶液(50∶50)(每100mL中加十二烷基硫酸钠0.4g,再以磷酸调节pH值为4.0),流速为1.0mL·min^-1,柱温为35℃,检测波长为345nm。结果盐酸小檗碱的线性范围为0.3582μg^1.4321μg(R=0.9999),平均回收率为100.32%(N=6),四批样品含量测定结果均值为:本品每1mL含盐酸小檗碱为2.39mg。结论本方法专属性强,重现性好,且稳定,可靠。

OBJECTIVE To establish the method of determinating the content of berberine hydrochloride in Hu Huang burn liniment by HPLC.METHODSHPLC methods was used and Berberine hydrochloride was selectedas reference substance.The ZORBAX Eclipse plus C 18 column(250mm×4.6mm,5μm)was used.The mobile phase was acetonitrile-0.05mol·L-1 potassium dihydrogen phosphate solution(50∶50)(adding 0.4 g sodium dodecyl sulfate per 100mL,and adjusting the pH value by phosphoric acid to 4.0),with a flow rate at 1.0mL·min^-1 and the column temperature was maintained at 35℃and wavelength at 345nm.RESULTS The linear range for detection of berberine hydrochloride was 0.3582-1.4321μg(r=0.9999).The average recovery rate of the method was 100.32%(n=6).The average content of the four batches of samples was:the content of berberine hydrochloride was 2.39mg per mL.CONCLUSION The method was reliable and stable withgood reproducibility and strong specificity.