Content and Dissolution Determination of Berberine Hydrochloride in Fengshi Qutong Capsule by HPLC / 中国药房

ABSTRACT

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 preparationthe column was Waters Xbridge C18 with mobile phase of acetonitrile-0.05 mol/L sodium hydrogen(4555,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=0.9999);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.