Action and use
Monoamine oxidase inhibitor; antidepressant.
Definition
Phenelzine Tablets contain Phenelzine Sulfate. They are coated.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of phenelzine, C8H12N2
90.0 to 110.0% of the stated amount.
Identification
A. Shake a quantity of the powdered tablets containing the equivalent of 30 mg of phenelzine with 25 mL of
water for 5 minutes and filter. Make the filtrate alkaline with 5
m sodium hydroxide and extract with two 25 mL quantities of
chloroform. Extract the combined chloroform layers with two 25 mL quantities of 0.05
m sulfuric acid and dilute the combined extracts to 100 mL with 0.05
m sulfuric acid. The
light absorption of the resulting solution,
Appendix II B, in the range 230 to 350 nm exhibits three well-defined maxima, at 252, 258 and 263 nm.
B. Extract a quantity of the powdered tablets containing the equivalent of 30 mg of phenelzine with 10 mL of
water and filter. Make 5 mL of the filtrate alkaline with 5
m sodium hydroxide and add 1 mL of
cupri-tartaric solution R1. A red precipitate is produced.
C. Extract a quantity of the powdered tablets containing the equivalent of 45 mg of phenelzine with 5 mL of
water and filter. The filtrate yields the reactions characteristic of
sulfates,
Appendix VI.
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing the equivalent of 0.1 g of phenelzine add 20 mL of water and 2 mL of 2m hydrochloric acid, heat to boiling and boil for 30 seconds, stirring constantly. Add 25 mL of water, cool, add 2 g of sodium hydrogen carbonate and 50 mL of 0.05m iodine VS, stopper the flask and allow to stand for 90 minutes. Add 15 mL of 2m hydrochloric acid and titrate with 0.1m sodium thiosulfate VS using starch mucilage, added towards the end of the titration, as indicator. Repeat the operation without the powder. The difference between the titrations represents the amount of iodine required. Each mL of 0.05m iodine VS is equivalent to 3.405 mg of C8H12N2.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of phenelzine.