Perphenazine Tablets

General Notices

Action and use

Dopamine receptor antagonist; neuroleptic.

Definition

Perphenazine Tablets contain Perphenazine. They are coated.

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

Content of perphenazine, C₂₁H₂₆ClN₃OS

92.5 to 107.5% of the stated amount.

Identification

A. To a quantity of the powdered tablets containing 40 mg of Perphenazine add 10 mL of water and 2 mL of 1m sodium hydroxide, shake and extract with 15 mL of ether. Wash the ether layer with 5 mL of water, dry with anhydrous sodium sulfate and evaporate the ether to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of perphenazine (RS 265).

B. Extract a quantity of the powdered tablets containing 20 mg of Perphenazine with 10 mL of chloroform, filter and evaporate the filtrate to dryness. Dissolve the residue in 2 mL of methanol, pour into a solution of 0.4 g of picric acid in 10 mL of methanol at 50°, cool and allow to stand for 4 hours. The melting point of the precipitate, after recrystallisation from methanol, is about 248°, with decomposition, Appendix V A.

C. To a quantity of the powdered tablets containing 5 mg of Perphenazine add 5 mL of sulfuric acid and allow to stand for 5 minutes. A red colour is produced.

Tests

Related substances

Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase C and applying separately to the plate 50 µL of each of the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 20 mg of Perphenazine with 10 mL of ethanol (96%) and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with ethanol (96%).

Uniformity of content

Tablets containing less than 2 mg and/or less than 2% w/w of Perphenazine comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Record second-derivative ultraviolet absorption spectra of the following solutions, Appendix II B, in the range 210 to 290 nm. For solution (1) add 5 mL of water to one tablet, mix with the aid of ultrasound for 15 minutes or until the tablet has completely disintegrated, heat on a water bath for 3 minutes, swirling continuously and cool. Add 50 mL of ethanol (96%), mix with the aid of ultrasound for 2 minutes, shake for 5 minutes, dilute to 100 mL with ethanol (96%) and filter through a glass microfibre filter paper. Dilute the filtrate, if necessary, with ethanol (96%) to produce a solution containing 0.001% w/v of Perphenazine. Solution (2) contains 0.001% w/v of perphenazine BPCRS in ethanol (96%).

For each solution measure the amplitude from the peak at 265 nm to the trough at 255 nm. Calculate the content of C₂₁H₂₆N₃OS in each tablet using the declared content of C₂₁H₂₆N₃OS in perphenazine BPCRS.

Assay

For tablets containing less than 2 mg and/or less than 2% w/w of Perphenazine

Use the average of the individual results determined in the test for Uniformity of content.

For tablets containing 2 mg or more and 2% w/w or more of Perphenazine

Carry out the following procedure protected from light. Record second-derivative ultraviolet absorption spectra of the following solutions, Appendix II B, in the range 210 to 290 nm. For solution (1) add 50 mL of water to 10 tablets, mix with the aid of ultrasound for 15 minutes or until the tablets have completely disintegrated, heat on a water bath for 3 minutes, swirling continuously, cool, add 400 mL of ethanol (96%), mix with the aid of ultrasound for 2 minutes, shake for 5 minutes, dilute to 500 mL with ethanol (96%) and filter through a glass microfibre filter paper. Dilute the filtrate with ethanol (96%) to produce a solution containing 0.001% w/v of Perphenazine. Solution (2) contains 0.001% w/v of perphenazine BPCRS in ethanol (96%). Measure the amplitude from the peak at 265 nm to the trough at 255 nm. Calculate the content of C₂₁H₂₆N₃OS using the declared content of C₂₁H₂₆N₃OS in perphenazine BPCRS.