HPLC法测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱的含量

HPLC Quantitative Determination of Berberine Hydrochloride in Compound Berberine Tannic Acid Protein Capsule

目的:建立高效液相色谱法测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱含量的方法。方法:采用CAPCELL PAK C18柱(250mm×4.6mm,5μm),以磷酸盐缓冲液[0.05mol/L磷酸二氢钾溶液-0.05mol/L庚烷磺酸钠溶液(1∶1),含0.2%三乙胺,并用磷酸调节pH值至3.0]-乙腈(60∶40)为流动相,流速1mL/min,检测波长263nm,柱温30℃。结果:盐酸小檗碱进样量在0.2016～2.4192μg范围内呈良好线性关系(r=0.9998),平均回收率100.6%,RSD=1.3%(n=9)。结论:本方法结果准确,专属性强,重现性好,可作为复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱含量测定的方法。

Objective:To estabilsh an HPLC method for quantitative determination of berberine hydrochloride in compound berberine tannic acid protein capsule.Methods:The liquid chromatography was carried out using a CAPCELL PAK C18 column(250mm× 4.6mm,5μm).The mobile phase consisted of phosphate [0.05mol/L potassium dihydrogen phosphate solution and 0.05mol/L heptane sulfonate solution(1∶1),contioning 2% of triethylamine,and phosphate adjustable pH 3.0 straight]-acetonitrile(60∶40).The flow rate was 1.0mL/min.Detection wavelength was 263nm and the column temperature was 30℃.Results:Berberine hydrochloride had a good linear relationship between 0.2016～2.4192μg.The average recovery was 100.6%(RSD=1.3%(n=9)).Conclusion:The method was accurate with good specificity and reproducibility,and suitable for the determination of berberine hydrochloride in compound berberine tannic acid protein capsule.