Affiliation:
1. Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai, China
2. Inner Mongolia Jingxin Pharmaceutical Co., Ltd, Innermongolia, China
Abstract
Background and Objective:
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 the 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, including uracil, hypoxanthine, uric
acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan in KFX were determined
based on the HPLC fingerprints.
Results:
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics
Reference70 articles.
1. Desai, P.B.; Srivastava, A.K. Adsorptive stripping differential pulse. tammetric determination of metoprolol at Nafion-CNT-nano-composite film sensor. Sensor. Actuat. B-Chem. 2013,176,632-638. http://dx.doi.org/10.1016/j.snb.2012.10.073
2. Yilmaz,B.; Arslan,S.; Akba, V. Gas chromatography-mass spec-trometry method for determination of metoprolol in the patients with hypertension. Talanta. 2009,80(1),346-351. http://dx.doi.org/10.1016/j.talanta.2009.06.079 PMID: 19782235
3. Grassi.; G. Metoprolol in the treatment of cardiovascular disease: a critical reappraisal. Curr. Med. Res. Opin. 2018,34(9),1635-1643. http://dx.doi.org/10.1080/03007995.2018.1479245 PMID: 29781321
4. Chen, Y.Y.; Yang, W.P.; Zhang, Z.J. Determination of metoprolol in rabbit blood using capillary electrophoresis with laser-induced fluorescence detection. Chin. Chem. Lett. 2011,22(3),350-353. http://dx.doi.org/10.1016/j.cclet.2010.10.025
5. Jung,O.; Gechter, J.L.; Wunder,C.; Paulke,A.; Bartel,C.; Geiger,H.; Toennes, S.W. Resistant hypertension? Assessment of adheren-ce by toxicological urine analysis, J. Hypertens. 2013,31(4),766-774. http://dx.doi.org/10.1097/HJH.0b013e32835e2286 PMID: 23337469
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献