Identification
Triturate a quantity of Tablets,equivalent to about 250mg of tolazamide,with 50mLof chloroform,and filter.Evaporate the filtrate to dryness,and dry in vacuum at 60

for 3hours:the residue so obtained responds to
Identificationtest
Aunder
Tolazamide.
Dissolution á711ñ
Medium:
0.05MTris(hydroxymethyl)aminomethane,pH7.6,adjusted,if necessary,with hydrochloric acid to a pHof 7.6;900mL.
Apparatus 2:
75rpm.
Time:
30minutes.
Procedure
Determine the amount of C
14H
21N
3O
3Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 224nm of filtered portions of the solution under test,suitably diluted with
Dissolution Medium,in comparison with a Standard solution having a known concentration of
USP Tolazamide RSin the same medium.
[NOTESonicate the Standard solution until the Reference Standard is dissolved.
]
Tolerances
Not less than 70%(Q)of the labeled amount of C14H21N3O3Sis dissolved in 30minutes.
Assay
Internal standard preparation
,
Mobile phase,and
Standard preparationPrepare as directed in the
Assayunder
Tolazamide.
Assay preparation
Weigh and finely powder not less than 10Tablets.Weigh accurately a portion of the powder,equivalent to about 300mg of tolazamide,and transfer to a suitable container.Add 100.0mLof Internal standard solutionand about 20glass beads.Securely close the container,and shake vigorously for approximately 30minutes.Centrifuge,and use the clear liquid as the Assay preparation.
Procedure
Proceed as directed for
Procedurein the
Assayunder
Tolazamide.Calculate the quantity,in mg,of C
14H
21N
3O
3Sin the portion of Tablets taken by the formula:
100C(RU/RS),
in which the terms are as defined therein.