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Quality control of tuirejieduling granules using high-performance liquid chromatography fingerprint method and
Aixia Yang1, Xiaoxian Wang, Chaomei Xiong
1Laboratory 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.
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.
Materials And 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.
Conclusion:
The HPLC fingerprint was proved to be a reliable method for the quality control of Tuirejieduling granule.
