Study on Quality Standard for Pule′an Tablet

A quality standard for Pule′an Tablet is established. The qualitative identifications of Kaempferol-3-O-β-D-(2-O-β-D-glucosyl)glucopyranoside(KMP) in Pule′an Tablet were performed by TLC; Kaempferol-3,4′-di-O-β-D-glucoside (KMG) and Kaempferol 3-O-β-D-(2-O-β-D-glucosyl)glucopyranoside(KMP) in the formulation were quantified by HPLC. Under optimal conditions, KMG in Pule′an Tablet can be qualitatively and quantitatively identified. Calibration curves of KMG and KMP were found to be linear with in the ranges of 0. 011 2～2.244 0 and 0.011 6～2.236 0 mg/mL, respectively . The correlation coefficient of the calibration curve for the KMG and KMP were 0.999 7 and 0.999 6; the average recoveries were 97.7% and 103.3%, with RSD 1.39% and 1.51%, respectively. This reliable, accurate and specific method can be used for the quality control of Pule'an Tablet.