Article
β-(1→3) glucan from Saccharomyces cerevisiae: Validation of an analytical method for the quality control of a pharmaceutical formulation [β(1→3) glucano de Saccharomyces cerevisiae: Validatión de un método de análisis para el control de calidad de una formulatión farmacéutica]
Fecha
2008Autor
Veliz, R., T.
Noa Perez, M.
Noa, L., E.
Institución
Resumen
β(1→3) glucan, isolated from the cell wall of Saccharomyces cerevisiae, is a powerful biological response modifier (BRM) is the active ingredient of several pharmaceutical formulations for human and veterinary use. This polysaccharide has an unusually rigid lineal molecular configuration, which makes it insoluble. The aim of the present work was to validate an analytical method proposed for the quality control of β(1→3) glucan from S. cerevisiae, since there was not found any analytical procedure for this active ingredient in the international pharmacopoeias. The analytical method was validated; determining linearity, specificity, precision, accuracy and lineal range. The results showed a r2 = 0,9815 in the range from 5 to 30 mg of active ingredient (ranging from 25 to 150% of the active component in finished product); without interferences from the pharmaceutical vehicle or the remaining contaminating polysaccharides (manans) from the same yeast wall. The CV obtained was below 10% under all the analytical conditions tested, and a total recovery of 92,06%. These results allowed recommending the herein described analytic method as routine quality control procedure for the pharmaceutical form containing β (1→3) glucan.