OBJECTIVE: To establish a method for simultaneous determination of gallic acid, chlorogenic acid, paeoniflorin and paeonol in Fule granules. METHODS: HPLC method was adopted. The determination was performed on Ultimate XB-C18 column with mobile phase consisted of acetonitrile-0.05% phosphoric acid (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelengths were 270 nm(gallic acid,paeonol), 325 nm (chlorogenic acid) and 230 nm (paeoniflorin). The column temperature was 30 ℃, and sample size was 10 μL. RESULTS: The linear ranges of gallic acid, chlorogenic acid, paeoniflorin and paeonol were 0.076 2-1.524 μg(r=0.999 7), 0.037 6-0.751 μg (r=0.999 9), 0.030 3-0.606 μg (r=0.999 7), 0.020 6-0.412 μg(r=0.999 8), respectively. The limits of quantification were 0.353, 0.276, 0.421, 0.540 μg/mL, and the limits of detection were 0.121, 0.104, 0.148, 0.186 μg/mL. RSDs of precision, stability and reproducibility tests were all no more than 2.04%. The recoveries were 95.24%-100.47%(RSD=1.59%,n=9),99.49%-103.70%(RSD=2.27%, n=9), 96.27%-101.09%(RSD=1.94%,n=9), 95.05%-98.89%(RSD=1.22%,n=9), respectively. CONCLUSIONS: The method is simple, accurate and reproducible, and can be used for the simultaneous determination of gallic acid, chlorogenic acid, paeoniflorin and paeonol in Fule granules.