LIU Xue, XIAO Ting, QU Shu-yue, MA Ying, WU Lin-jing, ZHOU Wei, SHEN Xiang-chun, TAO Ling, XU Qian-li, MAO Xiang-jun
Objective： To establish an HPLC characteristic chromatogram of Keqing capsules and to simultaneously determine six index components including gallic acid,morphine,protocatechuic acid,codeine,bergenin and chlorogenic acid. Methods： The HPLC separation was carried out on Ultimate® AQ-C18 column（250 mm×4.6 mm,5 µm）. The mobile phase was acetonitrile（A）-0.1% phosphoric acid solution（B）with gradient elution. The flow rate was 1.0 mL·min-1,the detection wavelength was 220 nm and the column temperature was 30 ℃. Similarity analysis of 11 batches of preparations was performed by Chinese medicine chromatographic fingerprint similarity evaluation software（2012 version）with bergenin as the reference peak. Results： The HPLC characteristic chromatogram of Keqing capsules was established,19 common characteristic peaks were demarcated, 6 chemical components were identified,and the similarities were above 0.92. The linear ranges of gallic acid,morphine, protocatechuic acid,codeine,bergenin and chlorogenic acid were 0.050 4-1.260 0 µg（r=0.999 8）,0.100 4-2.510 0µg（r=0.999 9）,0.050 8-1.270 0 µg（r=0.999 9）,0.050 4-1.260 0 µg（r=0.999 9）,0.300 8-7.520 0 µg（r=0.999 8）and 0.140 8-3.520 0 µg（r=0.999 9）,respectively. The average recoveries（n=6）were 97.2%（RSD=1.6%）,97.5%（RSD=1.0%）,100.9%（RSD=1.3%）,104.0%（RSD=1.5%）,96.7%（RSD=1.3%）and 95.9%（RSD=1.9%）,respectively. The contents of the above-mentioned components in 11 batches of preparations were 0.346 6-0.545 3,0.774 7-1.073 0,0.096 9-1.021 0,0.314 6-0.687 3,2.687 1-3.073 0 and 1.065 0-1.535 6 mg·g-1,respectively. Conclusion： The established HPLC characteristic chromatograms and quantitative analysis methods offered comprehensive and effective evaluation approach for quality control of the Keqing capsules.
