黄金膏中盐酸小檗碱的定性鉴别与含量测定Δ

摘要

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 μg/ml(r=0.999 0);RSDs of preci-sion,stability and reproducibility tests were lower than 3%;recovery was 97.7%-102.1%(RSD=1.68%,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.%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＝0.9990）；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。