黄金膏中盐酸小檗碱的定性鉴别与含量测定

Qualitative Identification and Content Determination of Berberine Hydrochloride in Huangjin Paste

目的：建立黄金膏中盐酸小檗碱的定性鉴别与含量测定方法。方法：采用薄层色谱（TLC）法对制剂中的盐酸小檗碱进行定性鉴别,采用高效液相色谱法对制剂中盐酸小檗碱进行含量测定。色谱柱为Symmetry Shield Rp-18,流动相为乙腈-0.1%磷酸溶液（50∶50,V/V）,流速为1.0 ml/min,检测波长为265 nm,柱温为30℃,进样量为10μl。结果：制剂中盐酸小檗碱的TLC斑点清晰、分离度好。盐酸小檗碱检测质量浓度线性范围为2.5～20.0μg/ml（r=0.999 0）;精密度、稳定性、重复性试验的RSD〈3%;加样回收率为97.7%～102.1%,RSD为1.68%（n=6）。结论：该方法简便易行、准确、重复性好,可用于黄金膏中盐酸小檗碱的定性鉴别与含量测定。

OBJECTIVE. To establish a method for the qualitative identification and content determination of berberine hydro- chloride in Huangjin paste. METHODS： TLC was adopted for the qualitative identification of berberine hydrochloride and HPLC was conducted for the content determination of berberine hydrochloride in preparation. The column was Symmetry Shield Rp-18 with mobile phase of acetonitrile-0.1% phosphoric acid （50：50, V/V） at a flow rate of 1.0 ml/min, detection wavelength was 265 nm, column temperature was 30 ℃ and injection volume was 10 μl. RESULTS： TLC spots of berberine hydrochloride in prepara- tion were clear and well-separated. The linear range of berberine hydrochloride was 2.5-20.0 gg/ml （r=0.999 0）; RSDs of preci- sion, stability and reproducibility tests were lower than 3% ; recovery was 97.7%-102.1% （RSD=l.68% , n=6）. CONCLUSI- ONS： The method is simple, accurate and reproducible, and can be used for the qualitative identification and content determination of berberine hydrochloride in Huangjin paste.