Hydroflumethiazide Tablets

General Notices

Action and use

Thiazide diuretic.

Definition

Hydroflumethiazide Tablets contain Hydroflumethiazide.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of hydroflumethiazide, C8H8F3N3O4S2

92.5 to 107.5% of the stated amount.

Identification

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in acetone.

(1) Shake a quantity of the powdered tablets containing 10 mg of Hydroflumethiazide with 10 mL of solvent for 10 minutes and filter.
(2) 0.1% w/v of hydroflumethiazide BPCRS.
chromatographic conditions
(a) Use as the coating silica gel GF254.
(b) Use the mobile phase as described below.
(c) Apply 5 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in a current of air and examine under ultraviolet light (254 nm) and then treat the plate by Method I and examine again.
mobile phase

ethyl acetate.

confirmation

By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds in colour and intensity to that in the chromatogram obtained with solution (2).

TEST

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in acetone.

(1) Shake a quantity of the powdered tablets containing 25 mg of Hydroflumethiazide with 25 mL of solvent for 10 minutes, filter, evaporate the filtrate to dryness and dissolve the residue in 2.5 mL of solvent.
(2) Dilute 1 volume of solution (1) to 100 volumes.
chromatographic conditions
(a) Use as the coating silica gel G.
(b) Use the mobile phase as described below.
(c) Apply 10 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in a current of air and reveal the spots by Method I.
mobile phase

ethyl acetate.

limits

Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1%).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powder containing 15 mg of Hydroflumethiazide with 50 mL of methanol for 10 minutes and dilute to 100 mL with methanol. Mix, filter, dilute 10 mL of the filtrate to 100 mL with methanol and measure the absorbance of the resulting solution at the maximum at 273 nm, Appendix II B. Calculate the content of C8H8F3N3O4S2 taking 595 as the value of A(1%, 1 cm) at the maximum at 273 nm.