HPLC-DAD法同时测定九味痔疮胶囊中6个成分的含量

Simultaneous determination of 6 components in Jiuwei Zhichuang capsules by HPLC-DAD

目的:建立同时测定九味痔疮胶囊中鞣花酸、虎杖苷、表小檗碱、盐酸黄连碱、盐酸巴马汀、盐酸小檗碱6个成分含量的HPLC法。方法:通过盐酸-甲醇溶液(1∶99)水浴加热结合超声处理的方式对样品进行提取,采用XBridge C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈(A)-0.025 mol·L^-1磷酸二氢钾溶液(B)为流动相进行梯度洗脱(0~30 min,15%A→50%A),流速为1.0 mL·min-1,柱温为25℃,进样量为10μL,检测波长为345 nm。结果:测定的6个成分在所取质量浓度范围内均具有良好的线性关系(r≥0.9998),精密度、稳定性和重复性良好,平均加样回收率为98.1%~98.8%,RSD为1.2%~2.0%。5批九味痔疮胶囊样品中测得的鞣花酸、虎杖苷、表小檗碱、盐酸黄连碱、盐酸巴马汀、盐酸小檗碱平均含量分别为1.10%、0.28%、0.25%、0.42%、0.33%、1.32%。结论:该方法操作简单,准确可靠,实用性强,可为完善九味痔疮胶囊的质量控制提供参考依据。

Objective:To establish an HPLC method for simultaneous determination of 6 components including ellagic acid,polydatin,epiberberine,coptisine hydrochloride,palmatine hydrochloride,and berberine hydrochloride in Jiuwei Zhichuang capsules.Methods:The sample was extracted with ultrasonic treatment by hydrochloric acid-methanol solution(1∶99)in heating water bath.XBridgeTM C18(4.6 mm×250 mm,5μm)column was adopted.The gradient elution(0-30 min,15%A→50%A)was carried out with acetonitrile(A)-0.025 mol·L^-1 potassium dihydrogen phosphate solution(B)as mobile phase.The flow rate was 1.0 mL·min-1,the column temperature was 25℃,the injection volume was 10μL,and the detection wavelength was 345 nm.Results:The linear relationship of the 6 components was all excellent(r≥0.9998),and the results of precision,stability tests and repeatability were all good,the average recovery rates were 98.1%-98.8%with RSDs of 1.2%-2.0%.The average contents of ellagic acid,polydatin,epiberberine,coptisine hydrochloride,palmatine hydrochloride and berberine hydrochloride in 5 samples were 1.10%,0.28%,0.25%,0.42%,0.33%and 1.32%,respectively.Conclusion:This method is simple,accurate,reliable and practical.It can provide reference for improving the quality of Jiuwei Zhichuang capsules.