Análise das propriedades físico-químicas da glucosamina sulfato comercial, uma matéria-prima utilizada em formulações farmacêuticas

Fernanda B. M. Malheiros; Samyr M. Querobino; Simone D. Corso; Carlos Alberto-Silva

doi:10.5585/conssaude.v14n3.5290

Authors

Fernanda B. M. Malheiros Universidade Nove de Julho; São Paulo, SP
Samyr M. Querobino Universidade Federal do ABC
Simone D. Corso Universidade Nove de Julho
Carlos Alberto-Silva Universidade Federal do ABC - UFABC, Santo André, SP

DOI:

https://doi.org/10.5585/conssaude.v14n3.5290

Keywords:

Chemistry, pharmaceutical, Glucosamine, Quality control.

Abstract

Introduction: The raw materials quality in the manipulation pharmacies are determined by Brazilian Health Surveillance Agency (ANVISA), but the protocols described may not be appropriate to analyze their physicochemical properties. Objective: To compare the physicochemical properties of glucosamine sulfate from two different suppliers with results obtained in the manipulation pharmacy. Methods: The organoleptic characteristics, pH, solubility and density of glucosamine samples (n=50) were analyzed according to the Brazilian Pharmacopoeia and Official Compendium and compared the technical reports of the suppliers. The results were analyzed by the Kolmogorov-Smirnov test, intraclass correlation coefficient (CCI) and Bland-Altman. Results: CCI analyses showed low reproducibility for pH and density test in the samples tested. In addition, Bland-Altman analysis indicated pH values and density of suppliers were underestimated or overestimated compared to the pharmacy. Conclusion: Physicochemical properties of glucosamine are appropriate according to Anvisa specifications, but new more sensitive techniques should be employed to ensure the glucosamine quality in the formulations.