title: HPLC and chemometrics for the quality consistency evaluation of Shuanghuanglian injection.
abstract: A high-performance liquid chromatography method with diode array detection was developed for simultaneous analysis of organic acids (chlorogenic acid, caffeic acid, 4,5-dicaffeoylquinic acid) and flavonoids (baicalin, baicalein, wogonin) in Shuang-huang-lian injection, a traditional Chinese medicine being prescribed widely for anti-bacterial, anti-viral and immunostimulant activity. All calibration curves showed good linear correlation (r(2) > 0.9997) within the test ranges. Validation proved that the repeatability of the method was good and recovery was satisfactory. The validated method was successfully applied to 24 batches of Shuang-huang-lian injection. The result showed that there was a great variation among different samples. Principal component analysis further proved considerable variations among the samples from eight manufacturers, and suggested that chlorogenic acid and baicalin might have the greatest variations among the 24 batches. In conclusion, these results demonstrated that the method proposed was very useful for the analysis and quality consistency evaluation of Shuang-huang-lian injection.
authors.affiliation: China Academy of Chinese Medical Sciences, China Academy of Traditional Chinese Medicine, Beijing 100700, China National Institute for Food and Drug Control, Beijing 100050, China luan9896@126.com.
authors.forename: Lan
authors.initials: L
authors.lastname: Luan
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Gangli
authors.initials: G
authors.lastname: Wang
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Ruichao
authors.initials: R
authors.lastname: Lin
mesh_terms: D000146:Acids, Carbocyclic / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D005419:Flavonoids / Q000032:analysis; D057230:Limit of Detection; D016014:Linear Models; D025341:Principal Component Analysis; D015203:Reproducibility of Results
chemical_list: D000146:Acids, Carbocyclic; D004365:Drugs, Chinese Herbal; D005419:Flavonoids; C516400:shuang-huang-lian