Study on Quality Standard for Siwei Jiangmei Tablets / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard for Siwei jiangmei tablets. METHODS:TLC method was used for the qualitative identification of Salvia miltiorrhiza,Artemisiae Scopariae Herba and Taraxaci Herba. HPLC method was adopted for the content determination of chlorogenic acid. The determination was performed on Agilents TC-C18column with mobile phase consisted of acetonitrile-3% acetic acid(1090,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 327 nm,and column temperature was 25 ℃. The sample size was 10 μL. RESULTS:TLC spots of S. miltiorrhiza, Artemisiae Scopariae Herba and Taraxaci Herba were clear and well-separated without interference from negative control. The linear range of chlorogenic acid was 0.26-0.79 μg for(r=0.999 9). The limits of quantitation and detection were 0.26,0.12 μg, respectively. RSDs of precision,stability and reproducibility tests were lower than 1.0%. The recoveries were 96.11%-101.96%(RSD=1.98%,n=9). CONCLUSIONS:Established standard can be used for quality control of Siwei jiangmei tablets.