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Abstract
A colorimetric method is described for the quantitative determination of tolbutamide in pharmaceutical dosage forms. The procedure is based on the interaction of n -butylamine, liberated in situ from tolbutamide, and ninhydrin to form a blue complex which can be quantitated spectrophotometrically at 585 mμ. No color is produced by p -toluenesulfonamide or dibutylurea, two possible decomposition products of tolbutamide. Urea and its acyl derivatives, carbamates, amidines, guanidine, and common tablet excipients do not undergo die reaction. A modified procedure is described for the removal of n -butylamine, a major hydrolytic product of tolbutamide, from samples of the drug that have undergone decomposition. Results of the application of the assay procedure to a stability study of tolbutamide tablets are presented.
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