Fingerprint Analysis of Compound Shuanghua Tablets and Content Determination of Multi-Index Components
Objective To establish the fingerprint of Compound Shuanghua Tablets and evaluate their quality based on the chemical pattern analysis.Methods The high-performance liquid chromatography(HPLC)method was adopted.The chromatographic column was the Shimadzu Wondasil C18 column(250 mm×4.6 mm,5 µm),the mobile phase was acetonitrile-0.05%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,multiple wavelengths were adopted(278 nm at 0-20 min,330 nm at 20-45 min,278 nm at 45-75 min),the column temperature was 30℃,and the injection volume was 20 µL.The fingerprint of 10 batches of samples was established,the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012A)was used for similarity evaluation,and the common peaks were marked.The partial least squares-discriminant analysis(PLS-DA)method was used to analyze the chemical patterns of common peaks,the differential biomarkers were screened,and their contents were determined.Results A total of 23 common peaks were marked in the fingerprint.The similarity of 10 batches of samples was greater than 0.950.Eight differential biomarkers were screened.The linear ranges of(R,S)-goitrin,chlorogenic acid,caffeic acid,galuteolin,andrographolide,phillyrin,quercetin,and dehydroandrographolide were 12.74-127.42 µg/mL,223.98-2 239.78 µg/mL,25.83-258.33 µg/mL,17.42-174.19 µg/mL,10.05-100.54 µg/mL,20.48-204.84 µg/mL,32.66-326.61 µg/mL,18.63-186.29 µg/mL(r>0.998 0,n=6)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above eight biomarkers were 101.37%,100.08%,99.36%,102.31%,101.18%,98.46%,99.09%,102.34%with RSDs of 1.39%,2.52%,1.69%,2.22%,2.31%,1.88%,1.64%,1.72%(n=6)respectively.Conclusion The established method is simple,fast,stable,feasible,specific,accurate and reliable,which can be used for the quality evaluation of Compound Shuanghua Tablets.
万方数据
维普
