Hydroflumethiazide
2H-1,2,4-Benzothiadiazine-7-sulfonamide, 3,4-dihydro-6-(trifluoromethyl)-, 1,1-dioxide. 3,4-Dihydro-6-(trifluoromethyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide ![]() ![]() ![]() » Hydroflumethiazide contains not less than 98.0 percent and not more than 102.0 percent of C8H8F3N3O4S2, calculated on the anhydrous basis.
Packaging and storage
Preserve in tight containers.
USP Reference standards
![]() ![]() USP 2,4-Disulfamyl-5-trifluoromethylaniline RS. USP Hydroflumethiazide RS.
Identification
A:
Infrared Absorption
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Solution:
10 µg per mL.
Medium:
methanol.
pH
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Water, Method I
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Residue on ignition
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Heavy metals, Method II
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Selenium
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Diazotizable substances
Standard preparation
Transfer 10.0 mg of USP 2,4-Disulfamyl-5-trifluoromethylaniline RS to a 50-mL volumetric flask, dissolve in and dilute with acetone to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix.
Test preparation
Transfer 100 mg to a 50-mL volumetric flask, dissolve in 5 mL of acetone, dilute with water to volume, and mix.
Procedure
Transfer 5.0 mL each of the Standard preparation, the Test preparation, and a solution of acetone in water (1 in 10) to provide the blank, to separate 25-mL volumetric flasks. To each flask add 2.0 mL of dilute hydrochloric acid (1 in 5), and immediately add 1 mL of freshly prepared sodium nitrite solution (1 in 100). Mix, and allow to stand for 5 minutes. Add 1 mL of freshly prepared ammonium sulfamate solution (1 in 10) to each flask, mix, and allow to stand for 1 minute, with frequent swirling. Add 1 mL of a freshly prepared solution of N-(1-naphthyl)ethylenediamine dihydrochloride (1 in 1000), and mix. After 1 minute, dilute with water to volume, and mix. Concomitantly, and within 5 minutes after mixing, taking care to establish the same elapsed time for each solution, determine the absorbances of the solutions in 1-cm cells at 518 nm, with a suitable spectrophotometer, using the blank to set the instrument: the absorbance of the solution from the Test preparation does not exceed that of the solution from the Standard preparation, corresponding to not more than 1.0% of diazotizable substances.
Assay
Transfer about 50 mg of Hydroflumethiazide, accurately weighed, to a 100-mL volumetric flask, add methanol to volume, and mix. Transfer 2.0 mL of this solution to a second 100-mL volumetric flask, dilute with methanol to volume, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Hydroflumethiazide RS in the same medium having a known concentration of about 10 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 273 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C8H8F3N3O4S2 in the Hydroflumethiazide taken by the formula:
5C(AU / AS)
in which C is the concentration, in µg per mL, of USP Hydroflumethiazide RS in the Standard solution; and AU and AS are the absorbances of the solution of Hydroflumethiazide and the Standard solution, respectively.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 2586
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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