Tolazamide Tablets
Action and use
Inhibition of ATP-dependent potassium channels (sulfonylurea); treatment of diabetes mellitus.
Definition
Tolazamide Tablets contain Tolazamide.
Content of tolazamide, C14H21N3O3S
95.0 to 105.0% of the stated amount.
Identification
Triturate a quantity of the powdered tablets containing 0.25 g of Tolazamide with 50 mL of acetone and filter. Evaporate the filtrate to dryness and dry at 60° at a pressure of 2 kPa for 3 hours. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of tolazamide (RS 342).
Tests
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
23 volumes of 13.5m ammonia, 60 volumes of cyclohexane, 100 volumes of methanol and 200 volumes of chloroform.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense that the spot in the chromatogram obtained with solution (2) (0.5%).
Assay
Weigh and powder 20 tablets. Shake a quantity of the powdered tablets containing 0.5 g of Tolazamide with 50 mL of chloroform, filter, wash the residue with chloroform and evaporate the combined filtrate and washings to dryness. Dissolve the residue in 20 mL of butan-2-one with the aid of gentle heat. Allow to cool, add 30 mL of ethanol (96%) and titrate the resulting solution with 0.1m sodium hydroxide VS using phenolphthalein solution R1 as indicator. Each mL of 0.1m sodium hydroxide VS is equivalent to 31.14 mg of C14H21N3O3S.