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Revista Brasileira de Ciências Farmacêuticas

Print version ISSN 1516-9332

Abstract

MARTINS, Janaina Diniz et al. Glibenclamide determination by derivative ultraviolet spectrophotometry for test or dissolution profile assessment in tablets. Rev. Bras. Cienc. Farm. [online]. 2007, vol.43, n.1, pp. 63-70. ISSN 1516-9332.  http://dx.doi.org/10.1590/S1516-93322007000100008.

Glibenclamide (GLIB) or glyburide, a second-generation oral hypoglycemic drug, is used in the tablet form for the treatment of diabetes mellitus. Because of the low aqueous solubility of this sulfonylurea, a low drug release in the dissolution test may occur, hence, causing variabilility in the treatment. GLIB methanolic solution shows UV absorption maxima in l 210 nm, 227.5 nm and 300 nm. After released from tablets in the dissolution test, its spectrophotometric determination is difficult due to the low drug concentration in solution (5 mg GLIB tablets, medium volume 900 mL, 0.56 mg%). In addition, it presents a low absorption in the characteristic wavelength of l 300 nm. Up to date, there is no method recommendation for GLIB determination in tablet monographs in many of national or foreign official compendia. For this reason, the dissolution test performance lacks uniformity by official recommended procedures, to prove pharmaceutical equivalence to the reference drug, for generic candidates. GLIB spectrophotometric determination is investigated by first and second derivative orders (peaks at l 238 nm and 218 nm, respectively in 0.1 mol L-1 phosphate buffer solution) using reference and test tablets containing 5 mg of GLIB per unit dose.

Keywords : Glibenclamide; Ultraviolet derivative spectrophotometry; Diabetes mellitus; Dissolution profile.

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