ABSTRACT
Objective: To develop the quality standard for Shenmai Dihuang Pills (SDP). Methods: The TLC methods applied to identify MoutanCortex, CorniFructus, Alismatis Rhizoma, and GlehniaeRadix in the formulation were carried out according to the methods recorded in general rules of Chinese Pharmacopeia (2015 edition, volume 4). The contents of psoralen, iso psoralen, and paeonol were analyzed by high performance liquid chromatography on a Diamonsil C18 column (250 mm ×4.6 mm, 5μm) with the mobile phase of acetonitrile (A)-0.1% formic acid (B) by gradient elution at a flow rate of 1.0 mL/min. The detection wavelength was set at 254 nm and the column temperature was controlled at 30℃. Results: There were good specificities of TLC for MoutanCortex, CorniFructu, Alismatis Rhizoma, and Glehniae Radix. The methodology validation for the assay of psoralen, iso psoralen, and paeonol presented that they were in good linear correlation in the ranges of 6.531-58.78, 6.115-55.04 and 20.40-183.6 μg/mL, with the regression equations of Y =1.523×104X-1.209×104 (r = 0.999 9), Y =1.809×104 X-1.523×104 (r = 0.999 9), and Y =2.760 ×104 X-1.683 ×104 (r = 0.999 9), respectively. The average recoveries were 100.4% (RSD 1.1%), 101.5% (1.3%), and 101.5% (0.79%).The content ranges of psoralen, isopsoralen, and paeonol from five different batches of SDP were 322.1-331.0, 298.0-350.1, and 929.5-982.7 μg/g, respectively. Conclusion: The established quality of TLC and HPLC methods are specific, reliable, accurate, and suitable, which can be successfully applied to the quality control for the preparation.