Abstract: A quality control method to quantify berberine and leonurine in Lishitonglin Granules via HPLC was established.The content of berberine was determined using the Diamonsil-C18 chromatographic column (250 mm×4.6 mm,5 μm) and acetonitrile-0.1% phosphoric acid(50:50,V/V)solution with 0.1 g sodium dodecyl sulfate per 100 mL of the solution as the mobile phase. The flow rate was 1.0 mL/min, and the detection wavelength was 265 nm. The content of leonurine was determined using the Diamonsil-C18 chromatographic column(250 mm×4.6 mm,5 μm).The mobile phase was acetonitrile-0.1% phosphoric acid solution (24:76, V/V) containing 0.4% sodium octane sulfonate. The flow rate was 1.0 mL/min, and the detection wavelength was 277 nm. The results showed that berberine was linear in the range of 0.052~0.520 μg(r=0.999 6) and leonurine was linear in the range of 0.039 6~0.396 0 μg (r=0.999 1). Further, there was a good linear relationship between injection volume and peak area. The recovery rate of berberine was 98.51%~102.1%, with relative standard deviation(RSD) of 2.08% (n=6).The recovery rate of leonurine was 99.90%~102.6%, with RSD of 1.13% (n=6). The established method has high specificity, good reproducibility, and ease of operation and can be used for the quality control analysis of Lishitonglin Granules.

Key words: Lishitonglin Granules, berberine, leonurine; quality control, HPLC