Study of Quality Evaluation Medthod of Compound Shilintong Tablets
Objective To establish a quality evaluation method for Compound Shilintong Tablets.Methods The chromatographic column was Waters Sunfire C18 column(200 mm×4.6 mm,5 µm),the mobile phase was acetonitrile-0.17%phosphoric acid aqueous solution(gradient elution),the flow rate was 0.9 mL/min,the detection wavelengths were 327 nm(chlorogenic acid,caffeic acid),334 nm(schaftoside,isoschaftoside)and 240 nm(mangiferin,loganin),the column temperature was 35℃,and the injection volume was 10 µL.With the schaftoside peak as the reference,the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine(Version 2012A)was used to establish the high-performance liquid chromatography(HPLC)fingerprint for 10 batches of samples,the common peaks were marked and identified,the similarity evaluation was performed,and the contents of six components were determined by the HPLC method.Cluster analysis and principal component analysis were used to evaluate the quality of 10 batches of samples.Results A total of 21 common peaks were marked,of which six were identified as schaftoside,isoschaftoside,chlorogenic acid,caffeic acid,loganin and mangiferin,with the similarity of 0.979 to 0.996.The linear ranges of the above six components were 13.96-279.3 µg/mL,5.468-109.4 µg/mL,10.07-201.3 µg/mL,2.762-55.24 µg/mL,5.390-107.8 µg/mL,5.252-105.0 µg/mL(r>0.999 0)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above six components were 100.00%,98.43%,99.91%,98.52%,99.35%,99.08%respectively,with the RSDs in the range of 0.30%to 1.14%(n = 6).The contents of the above six components in 10 batches of samples were in the range of 1.595 to 1.699 mg/g,0.581 1 to 0.602 4 mg/g,1.116 to 1.217 mg/g,0.299 4 to 0.310 5 mg/g,0.602 2 to 0.614 2 mg/g,0.601 7 to 0.624 5 mg/g respectively.Ten batches of samples were grouped into three categories,and the principal components one to three were the main factors affecting the quality of Compound Shilintong Tablets.Conclusion The established method is accurate,repeatable,stable and specific,which can be used for the quality control of Compound Shilintong Tablets.
Compound Shilintong TabletsHPLCfingerprintcontent determinationcluster analysisprincipal component analysisquality control
万方数据
维普
