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目的:建立高效液相色谱法(HPLC法)测定糖肾康丸中黄柏的盐酸小檗碱的含量。方法:测定盐酸小檗碱,采用Gemini C_(18)(250mm×4.6mm,5μm)色谱柱;以乙腈-0.1%磷酸(25∶75)为流动相;流速1.0mL·min~(-1);检测波长270nm;柱温30℃。结果:盐酸小檗碱的线性范围为0.0209~0.209μg(r=0.9977),平均加样回收率(n=6)为100.96%。结论:所建立的方法经方法学验证,快速简便,重复性好,专属性强,可作为中药制剂糖肾康丸的质量控制方法。
Objective: To establish a HPLC method for the determination of berberine hydrochloride in Tangshenjian Pills. METHODS: Berberine hydrochloride was determined by using Gemini C_ (18) (250 mm × 4.6 mm, 5 μm) column with acetonitrile-0.1% phosphoric acid (25:75) as mobile phase at a flow rate of 1.0 mL · min -1 ; Detection wavelength 270nm; column temperature 30 ℃. Results: The linear range of berberine hydrochloride was 0.0209 ~ 0.209μg (r = 0.9977). The average recovery rate (n = 6) was 100.96%. Conclusion: The established method is validated by methodology, which is rapid, simple, reproducible and specific. It can be used as a quality control method for Tangshenkang pill.