Trifluoperazine Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Trifluoperazine Tablets contain Trifluoperazine Hydrochloride. They are coated.
Content of trifluoperazine, C21H24F3N3S
92.5 to 107.5% of the stated amount.
Identification
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.