Amantadine Capsules

General Notices

Action and use

Viral replication inhibitor (influenza A); dopamine receptor agonist; treatment of influenza and Parkinson’s disease.

Definition

Amantadine Capsules contain Amantadine Hydrochloride.

The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of amantadine hydrochloride, C10H17N,HCl

95.0 to 105.0% of the stated amount.

Identification

A. Shake a quantity of the contents of the capsules containing 200 mg of Amantadine Hydrochloride in 10 mL of 0.1m hydrochloric acid on a water bath and filter. Add 1 mL of 5m sodium hydroxide to the filtrate, extract with 5 mL of dichloromethane, filter the dichloromethane layer through anhydrous sodium sulfate, wash the sodium sulfate with 2 mL of dichloromethane and evaporate the solution to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of amantadine (RS 006).
B. The contents of the capsules yield the reactions characteristic of chlorides, Appendix VI.

Tests

Related substances

Carry out the method for gas chromatography, Appendix III B, using 1 µL or other suitable volume of the following solution. Dissolve a quantity of the contents of the capsules containing 0.1 g of Amantadine Hydrochloride in 2 mL of water, add 2 mL of a 20% w/v solution of sodium hydroxide and 2 mL of chloroform and shake for 10 minutes. Separate the chloroform layer, dry over anhydrous sodium sulfate and filter.

The chromatographic procedure may be carried out using a glass column (1.8 m × 2 mm) containing a packing material prepared in the following manner. Mix 19.5 g of silanised diatomaceous support (Chromosorb G/AW/DMCS is suitable) with 60 mL of a 0.33% w/v solution of potassium hydroxide in methanol and evaporate the solvent under reduced pressure while slowly rotating the mixture. Dissolve 0.4 g of low-vapour pressure hydrocarbons (type L) (Apiezon L is suitable) in 60 mL of toluene (dissolution requires up to 5 hours), add this solution to the prepared silanised diatomaceous support and evaporate the solvent under reduced pressure while slowly rotating the mixture. Program the temperature of the column to increase from 100° to 200° at a constant rate of 6° per minute with the inlet port at 220° and the detector at 300°. Use a flow rate of 30 mL per minute for the carrier gas. Record the chromatogram for at least 2.5 times the retention time of the principal peak.

The area of any secondary peak is not greater than 0.3% and the sum of the areas of any secondary peaks is not greater than 1% by normalisation.

Assay

Dissolve a quantity of the mixed contents of 20 capsules containing 0.5 g of Amantadine Hydrochloride as completely as possible in 10 mL of water by heating on a water bath while shaking and cool. Add 10 mL of 5m sodium hydroxide and 50 mL of hexane, shake gently for 15 minutes and centrifuge. To 10 mL of the supernatant liquid add 30 mL of anhydrous acetic acid and carry out Method I for non-aqueous titration, Appendix VIII A, determining the end point potentiometrically. Each mL of 0.1m perchloric acid VS is equivalent to 18.77 mg of C10H17N,HCl.

Storage

Amantadine Capsules should be kept in an airtight container and protected from light.