Tranylcypromine Tablets

General Notices

Action and use

Monoamine oxidase inhibitor; antidepressant.

Definition

Tranylcypromine Tablets contain Tranylcypromine Sulfate. They are coated.

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

Content of tranylcypromine, C9H11N

95.0 to 105.0% of the stated amount.

Identification

A. The light absorption, Appendix II B, in the range 230 to 350 nm of the solution obtained in the Assay exhibits three maxima, at 258, 264 and 271 nm. The absorbances at the maxima are about 1.2, about 1.3 and about 0.96, respectively.
B. Suspend a quantity of the powdered tablets containing the equivalent of 5 mg of tranylcypromine in 0.5 mL of ethanol (96%) and add 5 mg of ninhydrin. A purple colour is produced within 15 minutes.
C. The powdered tablets yield the reactions characteristic of sulfates, Appendix VI.

TESTS

Related substances

Dissolve 10 mg of 4-chloroaniline (internal standard) in sufficient 0.1m hydrochloric acid to produce 20 mL (solution A). Carry out the method for gas chromatography, Appendix III B, using the following solutions. For solution (1) add 5 mL of 1m sodium hydroxide to 1 mL of solution A, extract with 10 mL of dichloromethane, add 1 mL of trifluoroacetic anhydride to the dichloromethane extract and allow to stand for 10 minutes. Evaporate the solution at a pressure of 2 kPa using a rotary evaporator and a water bath at 20° and dissolve the residue in 2 mL of dichloromethane. For solution (2) add 10 mL of 0.05m sulfuric acid to a quantity of the powdered tablets containing the equivalent of 75 mg of tranylcypromine, shake for 15 minutes, filter and wash the filter with two 5 mL quantities of 0.05m sulfuric acid. To the combined filtrate and washings add 1 mL of 5m sodium hydroxide and extract with 10 mL of dichloromethane. Dry the dichloromethane extract with anhydrous sodium sulfate, evaporate to about 5 mL without heating, add 1 mL of trifluoroacetic anhydride and allow to stand for 10 minutes. Evaporate the solvent at a pressure of 2 kPa using a rotary evaporator and a water bath at 20° and dissolve the residue in 2 mL of dichloromethane. For solution (3) add 10 mL of 0.05m sulfuric acid and 1 mL of solution A to a quantity of the powdered tablets containing the equivalent of 75 mg of tranylcypromine and complete the procedure described above, beginning at the words ‘shake for 15 minutes…’.

The chromatographic procedure may be carried out using a glass column (1.5 m × 4 mm) packed with acid-washed, silanised diatomaceous support (100 to 120 mesh) coated with 3% w/w of cyanopropylmethylphenyl methyl silicone fluid (OV-225 is suitable) and maintained at 170°.

In the chromatogram obtained with solution (3) the area of any secondary peak is not greater than that of the peak due to the trifluoroacetyl derivative of 4-chloroaniline (0.5%, calculated with reference to tranylcypromine sulfate).

Assay

Weigh and powder 20 tablets. To a quantity of the powder containing the equivalent of 30 mg of tranylcypromine add 60 mL of 0.1m sulfuric acid, shake for 30 minutes, add sufficient 0.1m sulfuric acid to produce 100 mL and filter. Measure the absorbance of the resulting solution at the maximum at 271 nm and at 282 nm, Appendix II B. Calculate the content of C9H11N from the difference between the absorbances taking 14.6 as the value of ΔA(1%, 1 cm).

Labelling

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