摘要
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.
出处
《中国药房》
CAS
北大核心
2016年第12期1716-1718,共3页
China Pharmacy