Triprolidine Tablets

General Notices

Action and use

Histamine H1 receptor antagonist; antihistamine.

Definition

Triprolidine Tablets contain Triprolidine Hydrochloride.

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

Content of triprolidine hydrochloride, C19H22N2,HCl,H2O

90.0 to 110.0% of the stated amount.

Identification

A. Extract a quantity of the powdered tablets containing 10 mg of Triprolidine Hydrochloride with ether, filter, discard the ether and dry the residue. Extract the residue with chloroform and evaporate to dryness. Add 0.1 mL of ether, stir and allow to evaporate. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of triprolidine hydrochloride (RS 356).
B. In the test for Related substances, the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (4).

Tests

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of equal volumes of butan-2-one and dimethylformamide as the mobile phase. Apply separately to the plate 5 µL of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing 10 mg of Triprolidine Hydrochloride with methanol, filter, evaporate to dryness and dissolve the residue in 1 mL of methanol. Solution (2) contains 0.020% w/v of Z-triprolidine hydrochloride BPCRS in methanol. Solutions (3) and (4) contain 0.010% w/v and 1.0% w/v respectively of triprolidine hydrochloride BPCRS in methanol. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). In the chromatogram obtained with solution (1) any spot corresponding to Z-triprolidine is not more intense than the spot in the chromatogram obtained with solution (2) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (3).

Assay

Weigh and powder 20 tablets. To a quantity of the powder containing 7.5 mg of Triprolidine Hydrochloride, add 15 mL of water and 1 g of sodium chloride, shake for 2 to 3 minutes and make alkaline with 5m sodium hydroxide. Extract with four 20 mL quantities of ether and wash the combined extracts with two 5 mL quantities of a mixture of equal volumes of a saturated solution of sodium chloride and water. Extract the ether solution with 20 mL of 0.1m hydrochloric acid, wash the ether with two 5 mL quantities of water and add the washings to the acid extract. Heat on a water bath for 30 minutes, cool and add sufficient water to produce 50 mL. Dilute 10 mL to 100 mL with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 290 nm, Appendix II B. Calculate the content of C19H22N2,HCl,H2O taking 290 as the value of A(1%, 1 cm) at the maximum at 290 nm.