Bendrofluazide Tablets

Bendroflumethiazide Tablets

Bendrofluazide Tablets contain not less than 92.5 per cent and not more than 107.5 per cent of the stated amount of bendrofluazide, C₁₅H₁₄F₃N₃O₄S₂.

Usual strengths. 2.5 mg; 5.0 mg.

Identification

2. Determine by thin layer chromatography (2.4.17), coating the plate withsilica gel GF254.

Mobile phase. Ethyl acetate.

Test solution. Disperse a quantity of the powdered tablets containing 10 mg of bendrofluazide with 10.0 ml of acetone, with the aid of ultrasound for 10 minutes, centrifuge, and use the clear supernatant liquid.

Reference solution. A 0.1 per cent w/v solution of bendrofluazide RS in acetone.

Apply to the plate 5 µl of each solution. After development, dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with reference solution.

Tests

Related substances. Determine by thin-layer chromatography (2.4.17), coating the plate with silica gel GF254.

Mobile phase. Ethyl acetate.

Test solution. Disperse a quantity of the powdered tablets containing 25.0 mg of bendrofluazide with 25.0 ml of acetone, with the aid of ultrasound for 10 minutes, filter, evaporate the filtrate to dryness and dissolve the residue in 2.5 ml of acetone.

Reference solution. Dilute 1.0 ml of the test solution to 100.0 ml with acetone.

Apply to the plate 10 µl of each solution. After development, dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. Any secondary spot in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution (1.0 per cent).

Other tests. Comply with the tests stated under Tablets.

Assay. Weigh and powder 20 tablets. Disperse a quantity of the powder containing 0.015 g of Bendrofluazide  with 50 ml of 0.1M sodium hydroxide with the aid of ultrasound for 10 minutes and add sufficient 0.1M sodium hydroxide to produce 100.0 ml, filter and dilute 10.0 ml of the filtrate to 100.0 ml with water and measure the absorbance of the resulting solution at the maximum at about 275 nm (2.4.7).

Calculate the content of C₁₅H₁₄F₃N₃O₄S₂ taking 410 as the specific absorbance at 275 nm.