Study on the Quality Standard of Compound Vaccariae Tablets / 中国药房

ABSTRACT

OBJECTIVE:To conduct supplementary study for quality standard for Compound vaccariae tablets. METHODS:TLC was used for the qualitative identification of Vaccariae;HPLC was used to determine the contents of vaccarin and anthranilic acid. The column was YMC-Pack Pro C18 with mobile phase of methanol- 0.3% phosphpric acid(gradient elution)at the flow rate of 1.0 ml/min,the detection wavelength was 280 nm,column temperature was 35 ℃ and volume size was 10 μl. RESULTS:The chromatographic spots were clear and well-separated without interference from negative control. The linear range was 0.055 7-2.228 7μg(r=0.999 9)for vaccarin and 2.011 4-40.227 9 μg(r=0.999 9)for anthranilic acid;RSDs of precision,stability and reproduc-ibility tests were no more than 1.01%;average recoveries were respectively 99.69%(RSD=1.11%,n=6) and 99.84%(RSD=1.18%,n=6). CONCLUSIONS:The method is simple,rapid and accurate with good reproducibility,and can be used for quality control of Compound vaccariae tablets.