Quality Evaluation of Compound Phenylbutazone and Spatholobus Stem Tablets Based on HPLC Fingerprint,Determination of Multi-index Components and Chemometrics Analysis
ZHANG Jie1, JIAO Wei-jie2a*, LEI Zhen2a, ZHANG Ge-yan1, GAO Yong-li1, SUN Zi-xue2b, MA Ling-zhen3
1. Department of Medical Supply, The Eighth People′s Hospital of Zhengzhou, Zhengzhou 450045, China; 2a. Department of Pharmacy, 2b. Department of Reproductive Medicine, Henan Province Hospital of TCM, Zhengzhou 450002, China; 3. School of Pharmacy, Bozhou Vocational and Technical College, Bozhou 236800, China
Abstract：OBJECTIVE To establish a quality evaluation method of Compound phenylbutazone and spatholobus stem tablets based on HPLC fingerprint, determination of multi-index components and chemometrics analysis. METHODS The chromatographic column was Waters Symmetry C18 column, and the column temperature was set at 30 ℃.The mobile phase was composed of acetonitrile-methanol (4∶1) and 0.05 mol·L-1 potassium dihydrogen phosphate solution flowing at 1.0 mL·min-1 in a gradient elution manner. The detection wavelength were set at 280 nm for (+)-catechin, epicatechin and medicarpin,215 nm for kirenol, darutoside and darutigenol, 240 nm for phenylbutazone, 6-gingerol and 8-gingerol. RESULTS The fingerprint of Compound phenylbutazone and spatholobus stem tablets was established. Seventeen common peaks were confirmed and nine of them were identified.The similarity of fingerprints of 10 batches of Compound phenylbutazone and spatholobus stem tablets from 3 different manufacturers was more than 0.95. (+)-Catechin, epicatechin, medicarpin, kirenol, darutoside, darutigenol, phenylbutazone, 6-gingerol and 8-gingerol showed good linear relationships within the ranges of 2.596-259.6, 3.148-314.8, 0.284 0-28.40, 3.876-387.6, 0.928 0-92.80, 0.512 0-51.20, 0.356 0-35.60, 2.268-226.8 and 0.432 0-43.20 μg·mL-1(r≥0.999 1), whose average recoveries were 99.69%, 100.02%, 96.91%, 100.06%, 98.94%, 98.42%, 97.88%, 99.32% and 97.32% with the RSDs of 0.78%, 0.67%, 1.24%, 0.84%, 1.03%, 1.36%, 1.15%, 0.94% and 1.46%, respectively. The results of cluster analysis showed that 10 batches of Compound phenylbutazone and spatholobus stem tablets were clustered into three groups, and the results of principal component analysis showed that the principal components 1-6 were the main factor affecting the quality evaluation of Compound phenylbutazone and spatholobus stem tablets. CONCLUSION The method is simple and repeatable, and it can be used to quality control and hensive evaluation of Compound phenylbutazone and spatholobus stem tablets.
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