Alimemazine Tablets
Action and use
Histamine H1 receptor antagonist; antihistamine.
Definition
Alimemazine Tablets contain Alimemazine Tartrate.
Content of alimemazine tartrate, C36H44N4S2,C4H6O6
92.5 to 107.5% of the stated amount.
Identification
Tests
Related substances
Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase A and applying separately to the plate 20 µL of each of the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1 g of Alimemazine Tartrate with 10 mL of a mixture of 95 volumes of methanol and 5 volumes of diethylamine and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with the same solvent mixture.
Assay
Carry out the following procedure protected from light. Add 150 mL of 0.1m hydrochloric acid to 10 tablets, shake for 10 minutes, mix with the aid of ultrasound for 1 minute, dilute with 0.1m hydrochloric acid to produce a solution containing 0.050% w/v of Alimemazine Tartrate and filter (solution A). Dilute 10 mL of solution A to 100 mL with water (solution B). To a further 10 mL of solution A add 2 mL of peroxyacetic acid solution, mix, allow to stand for 5 minutes and add sufficient water to produce 100 mL (solution C). Measure the absorbance of solution C at the maximum at 342 nm, Appendix II B, using solution B in the reference cell and measure the absorbance of solution B at the same wavelength using water in the reference cell. Repeat the procedure using a 0.05% w/v solution of alimemazine tartrate BPCRS in 0.1m hydrochloric acid in place of solution A, beginning at the words ‘Dilute 10 mL of solution A ...’ and calculate the content of C36H44N4S2,C4H6O using the declared content of C36H44N4S2,C4H6O in alimemazine tartrate BPCRS. The test is not valid if the absorbance of solution B is more than 0.10.