Diloxanide Tablets

General Notices

Action and use

Antiprotozoal.

Definition

Diloxanide Tablets contain Diloxanide Furoate.

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

Content of diloxanide furoate, C14H11Cl2NO4

95.0 to 105.0% of the stated amount.

Identification

Extract a quantity of the powdered tablets containing 0.2 g of Diloxanide Furoate with 20 mL of chloroform, filter and evaporate the filtrate to dryness. The dried residue complies with the following tests.

A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of diloxanide furoate (RS 103).
B. Burn 20 mg by the method for oxygen-flask combustion, Appendix VIII C, using 10 mL of 1m sodium hydroxide as the absorbing liquid. When the process is complete acidify the liquid with nitric acid and add silver nitrate solution. A white precipitate is produced.
C. Melting point, about 115°, Appendix V A.

TEST

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel HF254 as the coating substance and a mixture of 96 volumes of dichloromethane and 4 volumes of methanol as the mobile phase. Apply separately to the plate 5 µL of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing 0.5 g of Diloxanide Furoate with 5 mL of chloroform, centrifuge and use the supernatant liquid. For solution (2) dilute 1 volume of solution (1) to 400 volumes with chloroform. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powder containing 40 mg of Diloxanide Furoate with 150 mL of ethanol (96%) for 30 minutes, add sufficient ethanol (96%) to produce 200 mL, mix and filter. Dilute 10 mL of the filtrate to 250 mL with ethanol (96%) and measure the absorbance of the resulting solution at the maximum at 258 nm, Appendix II B. Calculate the content of C14H11Cl2NO4 taking 705 as the value of A (1%, 1 cm) at the maximum at 258 nm.

Storage

Diloxanide Tablets should be protected from light.