HPLC法测定风湿祛痛胶囊中盐酸小檗碱的含量和溶出度

Content and Dissolution Determination of Berberine Hydrochloride in Fengshi Qutong Capsule by HPLC

目的：建立测定风湿祛痛胶囊中盐酸小檗碱含量和溶出度的方法。方法：采用高效液相色谱法测定制剂中盐酸小檗碱的含量：色谱柱为Waters Xbridge C18,流动相为乙腈-0.05 mol/L磷酸二氢钠缓冲液（45∶55,V/V）,流速为0.5 ml/min,检测波长为345nm,柱温为30℃,进样量为10μl。采用转篮法测定盐酸小檗碱的溶出度。结果：盐酸小檗碱检测质量浓度线性范围为1.06~74.2μg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;加样回收率为96.8%~100.6%（RSD=1.6%,n=9）。样品30min的溶出度均〉80%。结论：该方法操作简便、稳定、重复性好,可用于风湿祛痛胶囊中盐酸小檗碱含量和溶出度的测定。

OBJECTIVE：To establish a method for content and dissolution determination of berberine hydrochloride in Fengshi qutong capsule. METHODS：HPLC was conducted to determine the content of berberine hydrochloride in the preparation： the column was Waters Xbridge C18 with mobile phase of acetonitrile-0.05 mol/L sodium hydrogen （45：55, V/V） at a flow rate of 0.5 ml/min, de- tection wavelength was 345 nm, column temperature was 30 ℃, and the injection volume was 10 μl. Rotating basket method was used to determine the dissolution of berberine hydrochloride. RESULTS：The linear range of berberine hydrochloride was 1.06-74.2 μg/ml （r=0.999 9） ; RSDs of precision, stability and reproducibility tests were lower than 1% ; recovery was 96.8%-100.6% （RSD=1.6% ,n=9）. The dissolution of samples in 30 min was higher than 80%. CONCLUSIONS： The method is simple and stable with good reproducibility, and can be used for content and dissolution determination of berberine hydrochloride in Fengshi qutong capsule.