金茵利胆口服液高效液相色谱指纹图谱及多成分含量同时测定研究

目的 建立金茵利胆口服液的高效液相色谱(HPLC)指纹图谱,以及多成分含量同时测定的方法.方法 色谱柱为DIKMA Diamonsil?C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1％磷酸水溶液(梯度洗脱),流速为0.9 mL/min,检测波长为254 nm,柱温为25℃,进样量为20μL.采用"...

HPLC Fingerprint of Jinyin Lidan Oral Liquid and Simultaneous Determination of Multiple Components in Jinyin Lidan Oral Liquid

Objective To establish a high-performance liquid chromatography(HPLC)fingerprint of Jinyin Li dan Oral Liquid and an HPLC method for the simultaneous determination of multiple components in Jinyin Lidan Oral Liquid.Methods DIKMA Diamonsil■C₁₈ column(250 mm×4.6 mm,5μm)was adopted,the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 0.9 mL/min,the detection wavelength was 254 nm,the column temperature was 25℃,and the injection volume was 20μL.The Similarity Evaluation System for TCM Chromatographic Fingerprint(2012 Edition)was used to construct the characteristic spectra of 21 batches of samples to calculate the similarity.The common peaks were determined and identified,the principal component analysis was conducted,and the contents of eight components were simultaneously determined.Results There were 18 common peaks in the HPLC fingerprints of 21 batches of samples with similarities≥0.947,of which eight common peaks were identified.Gallic acid,schaftoside,neohesperidin,berberine hydrochloride and ammonium glycyrrhizate scored higher in the three principal components in different batches of samples.The average contents of gallic acid,chlorogenic acid,schaftoside,glycyrrhizin,naringin,neohesperidin,berberine hydrochloride,and ammonium glycyrrhizinate in the eight batches of Jinyin Lidan Oral Liquid were 0.1361,0.1193,0.0919,0.1987,1.3905,1.6550,0.0899,0.0289 g/L,respectively.Conclusion The established HPLC fingerprint and the method for simultaneous determination of eight components can be used for the quality control of Jinyin Lidan Oral Liquid.