Trifluoperazine Tablets

General Notices

Action and use

Dopamine receptor antagonist; neuroleptic.

Definition

Trifluoperazine Tablets contain Trifluoperazine Hydrochloride. They are coated.

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

Content of trifluoperazine, C21H24F3N3S

92.5 to 107.5% of the stated amount.

Identification

A. Shake a quantity of the powdered tablets containing the equivalent of 20 mg of trifluoperazine with 30 mL of 1m hydrochloric acid for 10 minutes, filter, make the filtrate alkaline to litmus paper with 5m sodium hydroxide and extract with two 20 mL quantities of petroleum spirit (boiling range, 60° to 80°). Combine the extracts, wash with 10 mL of water, shake with 5 g of anhydrous sodium sulfate, filter and evaporate the filtrate carefully to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of trifluoperazine (RS 351).
B. Extract a quantity of the powdered tablets containing the equivalent of 5 mg of trifluoperazine with 5 mL of acetone, filter and evaporate the filtrate to dryness. Add 2 mL of sulfuric acid to the residue and allow to stand for 5 minutes. An orange colour is produced.
C. Extract a quantity of the powdered tablets containing the equivalent of 7 mg of trifluoperazine with 5 mL of acetone, filter and evaporate the filtrate to dryness. Separately, heat 0.5 mL of chromic-sulfuric acid mixture in a small test tube in a water bath for 5 minutes; the solution readily wets the sides of the tube and there is no greasiness. Add the residue to the acid mixture and heat again on a water bath for 5 minutes; the solution does not wet the sides of the tube and does not pour easily from the tube.

Tests

Uniformity of content

Tablets containing the equivalent of less than 2 mg and/or less than 2% w/w of trifluoperazine comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Place one tablet in a 100 mL graduated flask, add 50 mL of a mixture of 5 volumes of hydrochloric acid and 95 volumes of water, shake until the tablet has completely disintegrated, dilute to volume with the same solvent, mix and filter, discarding the first 10 mL of filtrate. Measure the absorbance of the filtrate at the maximum at 256 nm, Appendix II B. Calculate the content of C21H24F3N3S taking 743 as the value of A(1%, 1 cm) at the maximum at 256 nm.

Assay

Carry out the following procedure protected from light. Weigh and powder 20 tablets. Shake a quantity of the powder containing the equivalent of 5 mg of trifluoperazine for 15 minutes with 400 mL of a mixture of 5 volumes of hydrochloric acid and 95 volumes of water, dilute to 500 mL with the same mixture, mix and filter. Measure the absorbance of the filtrate at the maximum at 256 nm, Appendix II B. Calculate the content of C21H24F3N3S taking 743 as the value of A(1%, 1 cm) at the maximum at 256 nm.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of trifluoperazine.