Study on Quality Standard for Tussilago farfara Formula Granules / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for the establishment of quality standard of Tussilago farfara formula granules. METHODS： TLC method was used for qualitative identification of tussilagone in T. farfara formula granules. The content of tussilagone in T. farfara formula granule was determined by HPLC. The determination was performed on a Thermo ODS Hypersil C18 column with the mobile phase consisted of methanol-water （85 ∶ 15， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm， the column temperature was 25 ℃. Sample size was 20 μL.  RESULTS： TLC spots of tussilagone were clear and well-separated， without interference from negative control. The linear range of tussilagone was 1.39-27.75 μg/mL （r＝0.999 9）. The limits of quantification and detection were 0.153 87 and 0.051 42 μg/mL， respectively. RSDs of precision， stability and reproducibility tests were lower than 2％. The recoveries were 97.12％-103.96％ （RSD＝2.60％， n＝6）. CONCLUSIONS： The method is simple， accurate and reproducible， and suitable for quality control of T. farfara formula granules.