title: Quality control of tuirejieduling granules using high-performance liquid chromatography fingerprint method and simultaneous determination of four main active ingredients.
abstract: BACKGROUND
  The Tuirejieduling granule is a compound preparation made from four kinds of Chinese medicines. It is effective for anti-inflammation, antivirus, defervescence and anti-bacterium; however, its quality control standards have remained unknown.
  
  
  OBJECTIVE
  To establish a simple and accurate fingerprint method for quality control of the Tuirejieduling granule.
  
  
  METHODS
  The methanol extract of the Tuirejieduling granule was used for the fingerprint analysis and the four selected active ingredients (epigoitrin, phillyrin, saikosaponin A and glycyrrhetinic acid) in the extract were determined. The fingerprint method was performed on an Amethyst C18-P chromatography column by gradient elution with acetonitrile and aqueous phase (containing 0.5% H3PO4 (v/v), pH 3.0).
  
  
  RESULTS
  Under the optimal chromatographic condition, twenty peaks were chosen as fingerprint peaks of the Tuirejieduling granules extractions. The similarities of 10 batches of Tuirejieduling granule was more than 0.99. This indicates that the different batches of Tuirejieduling granules were under the consistent quality control. Good linear behaviors over the investigated concentration ranges were obtained with the values of R (2) higher than 0.99 for four studied active ingredients. The recoveries for spiked samples were in the range of 96.2-105.5%. The developed method was successfully applied to determine the contents of active constituents in different batches of Tuirejieduling granule.
  
  
  CONCLUSIONS
  The HPLC fingerprint was proved to be a reliable method for the quality control of Tuirejieduling granule.
authors.affiliation: Laboratory of Natural Medicinal Chemistry and Resource Evaluation, Department of Chinese Traditional Medicine, School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China ; Department of Pharmacy, Wuhan Integrated TCM & Western Medicine Hospital (Wuhan NO.1 Hospital), Wuhan, China.
authors.forename: Aixia
authors.initials: A
authors.lastname: Yang
authors.forename: Xiaoxian
authors.initials: X
authors.lastname: Wang
authors.forename: Chaomei
authors.initials: C
authors.lastname: Xiong
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.forename: Jinlan
authors.initials: J
authors.lastname: Ruan
keywords: Fingerprint; Tuirejieduling granules; high-performance liquid chromatography; quality control