Procedure for content uniformity
Place 1Tablet in a 100-mLvolumetric flask,add 10.0mLof water,and shake by mechanical means for 15minutes.Dilute with methanol to volume,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the subsequent filtrate quantitatively and stepwise,if necessary,with a mixture of methanol and water (9:1)to obtain a solution containing about 40µg of carbinoxamine maleate per mL.Concomitantly determine the absorbances of this solution and of a Standard solution of
USP Carbinoxamine Maleate RS,in the same medium having a known concentration of about 40µg per mL,in 1-cm cells,at the wavelength of maximum absorbance at about 260nm,with a suitable spectrophotometer,using a mixture of methanol and water (9:1)as the blank.Calculate the quantity,in mg,of C
16H
19ClN
2O·C
4H
4O
4in the Tablet taken by the formula:
(TC/D)(AU/AS),
in which
Tis the labeled quantity,in mg,of carbinoxamine maleate in the Tablet,
Cis the concentration,in µg per mL,of
USP Carbinoxamine Maleate RSin the Standard solution,
Dis the concentration,in µg per mL,of carbinoxamine maleate in the solution from the Tablet,based upon the labeled quantity per Tablet and the extent of dilution,and
AUand
ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.