Improvement of quality standard of Kangshen Granule

Abstract

Objective To improve the quality standard of Kangshen Granule establishing thin layer chromatography(TLC) qualitative identification method for Kangshen Granules and determination of hesperidin and puerarin in Kangshen Granule by high performance liquid chromatography (HPLC). Methods TLC method was used to identify the alizarin in Kangshen Granule; and the contents of puerarin and hesperidin were determined by HPLC; gradient elution was done with acetonitrile-1% formic acid as mobile phase; and the hesperidin and puerarin were determined at 284 nm wavelength. Results In TLC, there were spots of the same color at the corresponding positions of the sample solution, the control medicinal meterials, and the control drug; and the negative control had no interference. At the same time, a good linear relationship was obtained in puerarin within the range of 12.117 0 - 242.340 8 μg/ml, r=1.00, and the regression equation ypuerarin = 3 783.24x+230.27. A good linear relationship was obtained in hesperidin within the range of 7.867 4 - 157.3477 μg /ml, r=1.00, and the regression equation yhesperidin = 4 431.37x+32.87. The average recovery rates (n = 24) of puerarin and hesperidin were 99.3% (RSD = 1.28%) and 100.7% (RSD = 1.68%), respectively. Conclusions TLC method for the qualitative identification of alizarin in and HPLC method for the determination of hesperidin and puerarin in kangshen granule are simple, rapid, sensitive, specific, and reproducible, which can be used for the quality control of Kangshen Granule. Key words: Kangshen Granule; TLC; HPLC; Quality standard