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目的:建立黄柏地榆胶囊中盐酸小檗碱的高效液相色谱含量测定方法。方法:采用Shim-pack vp-ODS柱(250mm×4.6mm,5μm),以乙腈-0.05mol·L~(-1)磷酸二氢钾缓冲液(含三乙胺0.5%,磷酸调pH至3.0)(36:64)为流动相,流速为1.0ml·min~(-1),检测波长为345nm。结果:盐酸小檗碱在1.97~31.55μg·ml~(-1)范围内有良好线性关系,r=0.999 9。平均回收率98.6%,RSD为2.1%(n=6)。结论:方法简便、准确、重复性好,可用于该制剂的质量控制。
Objective: To establish a HPLC method for determination of berberine hydrochloride in Huangbai Diqi capsules. METHODS: A Shim-pack vp-ODS column (250mm×4.6mm, 5μm) was used with acetonitrile-0.05mol·L -1 potassium dihydrogen phosphate buffer (triethylamine 0.5%, pH adjusted to 3.0 by phosphoric acid (36:64) is a mobile phase with a flow rate of 1.0 ml·min -1 and a detection wavelength of 345 nm. RESULTS: Berberine hydrochloride had good linearity in the range of 1.97-31.55 μg·ml -1 , r=0.999 9. The average recovery rate was 98.6%, and the RSD was 2.1% (n=6). Conclusion: The method is simple, accurate and reproducible. It can be used for the quality control of the preparation.