Study on HPLC fingerprint and multi-index determination of Tongqiao Biyan tablets
Objective To establish an HPLC fingerprint of Tongqiao Biyan tablets(TBT)and a quantitative analysis method for six components including cimicifugoside,5-O-Methylvisammioside,Calycosin-7-O-beta-D-glucoside,Imperatorin,Isoimperatorin,and Atractylenolide-Ⅰ.Methods The AlltimaTM C18 column(250 mum × 4.6 mm,5 μm)was used with acetonitrile-0.2%formic acid solution as the mobile phase for gradient elution,and the detection wavelength was set at 254 nm.The TBT reference fingerprint was established using the similarity evaluation system of traditional Chinese medicine chromatographic fingerprints,and the similarity was evaluated.The contents of the six marker components were determined in Tongqiao Biyan tablets.Results In the established TBT reference fingerprint,a total of 10 common peaks were matched,and six marker components were identified using reference sub-stances:cimicifugoside(peak 1),calycosin-7-O-beta-D-glucoside(peak 2),5-O-methylvisammioside(peak 4),imperatorin(peak 7),isoimperatorin(peak 8),and atractylenolide-Ⅰ(peak 10),with similarity ranging from 0.991 to 0.998.The linear relationships between the peak area and the amount of the six components were good within the ranges of 0.051-0.605 4 μg(R2=0.999 2),0.008 2-0.327 3 μg(R2=0.999 3),0.014 3-0.570 3 μg(R2=1.000 0),0.030 7-1.228 8 μg(R2=1.000 0),0.014 7-0.589 7 μg(R2=1.000 0),and 0.002 3-0.091 8 μg(R2=1.000 0),respectively.The average recovery rates were 96.4%-102.2%,with RSD less than 3.0%(n=9),and the precision,stability,and repeatability RSDs were all less than 3.0%.Conclusion The estab-lished HPLC fingerprint and the content determination method are stable and controllable,suitable for the quality control of Tongqiao Biyan tablets.
Tongqiao Biyan tabletsHPLCfingerprintmulti-component quantitative analysisquality control