ABSTRACT
ObjectiveTo establish an HPLC analytic method for amygdalin inKuxingrenFormula Granules and HPLC characteristic chromatogram.MethodsRP-HPLC method was adopted. The determination was performed on Dionex C18 column (4.6 mm×250 mm, 5μm) with acetonitrile-0.1% phosphoric acid solution (8:92) at the flow rate of 0.6 mL/min. The detection wavelength was set at 207 nm and sample size was 10μL. The column temperature was 30℃. The peak of amygdalin was set as refernce, and 10 batches of samples were analyzed. TCM Chromatogram Fingerprint Similarity Evaluation System (2004 A) was adopted to evaluate similatity.Results The linear equation of amygdalin wasY=6.176×10-7X?3.058×10-3, with a good linear relationship in the range of 0.122 5–1.225μg (r= 0.999 8). The average recovery rate was 98.75% (RSD=1.30%). There were 6 common peaks in the characteristic chromatogram ofKuxingrenFormula Granules, and the similarity of 10 batches of samples was higher than 0.981. ConclusionThe HPLC method is simple, accurate and reproducible, which can be used for the quality control of Kuxingren Granules.