Simultaneous Determination of Asperosaponin Ⅵ and Tanshinone ⅡA in Yigong Granules by HPLC
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1.Guiyang Food and Drug Control and Testing Center, Guizhou Guiyang 550081, China; 2.Guizhou Medical Products Administration Inspection Center, Guizhou Guiyang 550081, China
Objective: To establish a high-performance liquid chromatography (HPLC) method for the simultaneous determination of asperosaponin Ⅵ and tanshinone ⅡA in Yigong Granules, in order to improve the quality control standard of this preparation. Methods: HPLC analysis was performed using an Agilent Eclipse Plus C18 column (4.6 mm×250 mm, 5 μm). The mobile phase consisted of 0.1% (v/v) phosphoric acid solution (A) and acetonitrile (B), with gradient elution according to a specified program. The flow rate was set at 1.0 mL·min-1, and the column temperature was maintained at 30 ℃. Detection wavelengths were set at 210 nm for asperosaponin Ⅵ and 270 nm for tanshinone ⅡA, based on their ultraviolet absorption characteristics. The injection volume was 10 μL. Results: Asperosaponin Ⅵ showed a good linear relationship within the concentration range of 23.575 0-707.250 0 μg·mL-1, with a correlation coefficient (r2) of 1.000 0. The average recovery rate was 96.4%, and the relative standard deviation (RSD) was 1.8% (n=6). Tanshinone ⅡA also exhibited a good linear relationship within the concentration range of 1.483 5-44.505 0 μg·mL-1, with an r2 of 1.000 0. The average recovery rate was 94.8%, and the RSD was 1.5% (n=6). Conclusion: A simple, accurate, reproducible, and stable HPLC method was successfully developed for the simultaneous and rapid determination of asperosaponin Ⅵ and tanshinone ⅡA in Yigong Granules. This method is reliable and practical, making it suitable for multi-component quality evaluation of the preparation.