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Fourier-transformed infrared spectroscopy, physicochemical and biochemical properties of chondroitin sulfate and glucosamine as supporting information on quality control of raw materials

Authors
  • Alberto-Silva, Carlos1
  • Malheiros, Fernanda Blini Marengo2
  • Querobino, Samyr Machado3
  • 1 Experimental Morphophysiology Laboratory Federal University of ABC (UFABC), Rua Arcturus, n° 03, Bloco Delta, São Bernardo do Campo, SP, 09606-070, Brazil , São Bernardo do Campo (Brazil)
  • 2 Adamantina University Center - UNIFAI, Rua Nove de Julho, 730, Adamantina, SP, 17800-000, Brazil , Adamantina (Brazil)
  • 3 Universidade do Estado de Minas Gerais - UEMG, Av. Juca Stockler, 1130, Bairro Belo Horizonte, Passos, MG, 37900-106, Brazil , Passos (Brazil)
Type
Published Article
Journal
Future Journal of Pharmaceutical Sciences
Publisher
Springer Berlin Heidelberg
Publication Date
Nov 23, 2020
Volume
6
Issue
1
Identifiers
DOI: 10.1186/s43094-020-00120-3
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundChondroitin sulfate (CS) and glucosamine (GLcN) are recommended for the restoration of the articular cartilage surface in patients affected by osteoarthritis. They are commercialized as pharmaceutical-grade products and as food supplements, and there are reports that they do not undergo the strict quality controls of pharmaceuticals. Herein, we evaluated the physicochemical parameters of two raw materials (CS and GlcN) obtained from two distinct suppliers in Brazil and compare the obtained data with the product specification provided by the manufacturer. Also, the homogeneity and purity grade of samples were analyzed by FT-IR spectroscopy.ResultsThe organoleptic properties and solubility of CS and GlcN samples obtained from pharmacy analyses and the supplier’s specifications are in accordance with the standards required by the Brazilian Health Regulatory Agency (ANVISA). However, the intraclass correlation coefficient (ICC) and Bland Altman analysis of pH and the density values of samples are statistically different between the suppliers. In addition, FT-IR analyses indicated that there is non-homogeneity in the CS and GlcN samples tested, showing that both manufacturers distribute the drugs in different concentrations, although both declare the same concentration in the product technical specifications.ConclusionIn summary, our study demonstrated that physicochemical parameters are insufficient to ensure product quality, and it is necessary to implement a more efficient protocol to ensure the quality of the final product.Graphical abstract

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