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Chemical Fingerprint Analysis and Simultaneous Determination of Nucleosides and Amino Acids in Kang Fu Xin Liquid by High Performance Liquid Chromatography with Diode Array Detector

Author(s):

Yuwen Wang, Shuping Li , Liuhong Zhang , Shenglan Qi, Huida Guan , Wei Liu, Xuemei Cheng , Li Liu, Liang Cheng and Changhong Wang *   Pages 1 - 13 ( 13 )

Abstract:


Background and Objectives: Kang Fu Xin liquid (KFX) is an official preparation made from the ethanol extract product from P. Americana. The present quality control method cannot control the quality of the preparation well. The aim of present study is to establish a convenient HPLC method for multicomponents determination combined with fingerprint analysis for quality control of KFX.

Methods: An HPLC-DAD method with gradient elution and detective wavelength switching program was developed to establish HPLC fingerprints of KFX, and 38 batches of KFX were compared and evaluated by similarity analysis (SA), hierarchical clustering analysis (HCA), and principal component analysis (PCA). Meanwhile, six nucleosides and three amino acids, uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan, in KFX were simultaneous determined based on the HPLC fingerprints.

Result: An HPLC method assisted with gradient elution and wavelength switching program was established and validated for multicomponents determination combined with fingerprint analysis of KFX. The results demonstrated that the similarity values of the KFX samples were more than 0.845. PCA indicated that peaks 4 (hypoxanthine), 7 (xanthine), 9 (tyrosine), 11, 13 and 17 might be the characteristic contributed components. The nine constituents in KFX, uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan, showed good regression (R2 > 0.9997) within test ranges and the recoveries of the method for all analytes were in the range from 96.74 to 104.24%. The limits of detections and quantifications for nine constituents in DAD were less than 0.22 and 0.43 μg•mL-1, respectively.

Conclusion: The qualitative analysis of chemical fingerprints and the quantitative analysis of multiple indicators provide a powerful and rational way to control the KFX quality for pharmaceutical companies.

Keywords:

Kang Fu Xin liquid, Periplaneta Americana, Fingerprints, Quality control

Affiliation:

Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine; The MOE Key Laboratory for Standardization of Chinese Medicines and Shanghai Key Laboratory of Compound Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Shanghai R&D Centre for Standardization of Chinese Medicines, 1200 Cailun Road, Shanghai 201203, , Inner Mongolia Jingxin Pharmaceutical Co., Ltd, Innermongolia, , Zhejiang Jingxin Pharmaceutical Co. Ltd., Zhejiang Province, , Shanghai R&D Centre for Standardization of Chinese Medicines, 1200 Cailun Road, Shanghai 201203



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