Method: Several chromatographic conditions such as mobile phase and C18 column with different suppliers for separation of geniposide in Gardenia Fructus dry extract, and several extraction conditions such as solvent, ratio of solvent and dry extract, and extraction time by ultrasonic, were investigated. Finally, the analytical procedure was validated according to ICH guidelines, including system suitability, selectivity, linearity and range, precision, accuracy and ruggedness.