HPLC-DAD法同时测定九味痔疮胶囊中6个成分的含量

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，5 μm）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10 μL，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≥0.999 8），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. XBridge^TM C₁₈(4.6 mm×250 mm,5 μm)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 10 μL,and the detection wavelength was 345 nm. Results: The linear relationship of the 6 components was all excellent (r ≥ 0.999 8),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.

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