HPLC测定不同厂家桂枝茯苓丸中丹皮酚及芍药苷

Determination on Content of Paeonol and Paeoniflorin in Guizhi Fuling Pills from Different Pharmaceutical Factories by HPLC

摘要:

目的: 建立同时测定桂枝茯苓丸丹皮酚和芍药苷含量的方法,比较不同厂家桂枝茯苓丸(浓缩丸)中丹皮酚和芍药苷的含量差异。 方法: 高效液相色谱法,C₁₈柱,流动相乙睛-0.1%磷酸水溶液,梯度洗脱,流速1.0 mL·min^-1,检测波长230 nm (0~17 min)→274 nm (17~26 min),进样量20 μL,柱温30℃。 结果: 丹皮酚的线性范围为2.02~22.40 μg(r=0.999 9),芍药苷的线性范围为2.40~20.26 μg(r=0.999 9),两者的平均加样回收率分别是99.5%,99.4%,精密度与重复性RSD均<1.5%。 结论: 所建立的色谱方法可以简便、准确地同时测定桂枝茯苓丸中丹皮酚和芍药苷的含量,精密度高,重复性好,各厂家生产的桂枝茯苓丸中丹皮酚和芍药苷的含量差别较大。该研究为全面评价桂枝茯苓丸的质量提供了依据。

Abstract:

Objective: To establish a determination method of paeonol and paeoniflorin content in GFW and to compare its content discrepancy in GFW from different pharmaceutical factories. Method: HPLC was used to simultaneously determine the content of paeonol and paeoniflorin. An Elite Hypersil BDS C₁₈(4.6 mm×250 mm, 5 μm) column was used for content determination. The mobile phase was acetonitrile-0.1% phosphoric acid aqueous solution. Flow rate was 1.0 mL·min^-1. The detection wavelength was set at 230 nm (0-17 min)→274 nm (17-26 min). The injection volume was 20 μL and column temperature was maintained at 30℃. Result: The linear range of paeonol was 2.02-22.40 μg (r=0.999 9); the linear range of paeoniflorin was 2.40-20.26 μg (r=0.999 9). The average recovery was 99.5%, 99.4%, and RSD was 0.96%, 0.81% (n=9) respectively. Conclusion: The established chromatographic method which had good repeatability can be used to determine the content of paeonol and paeoniflorin in GFW simply and accurately and can be used to evaluate the quality of GFW from different pharmaceutical factories.