Acebutolol Tablets
Action and use
Beta-adrenoceptor antagonist.
Definition
Acebutolol Tablets contain Acebutolol Hydrochloride.
Content of acebutolol, C18H28N2O4
95.0 to 105.0% of the stated amount.
Identification
The infrared absorption spectrum of a 0.7% w/w dispersion of the powdered tablets in potassium bromide, Appendix II A, is concordant with the reference spectrum of acebutolol hydrochloride (RS 380).
Tests
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in a solvent mixture of equal volumes of chloroform and methanol.
20 volumes of glacial acetic acid, 20 volumes of dimethylformamide and 60 volumes of chloroform.
In the chromatogram obtained with solution (1):
any secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.3%);
not more than two such spots are more intense than the spot in the chromatogram obtained with solution (3) (0.1%).
Disregard any spot remaining on the line of application.
Assay
Shake a number of whole tablets containing the equivalent of 4 g of Acebutolol with 250 mL of water until completely disintegrated, add sufficient water to produce 1000 mL, filter and dilute 10 mL of the filtrate to 250 mL with water. To 10 mL of this solution add 20 mL of 0.1m hydrochloric acid and sufficient water to produce 200 mL. Measure the absorbance of this solution, Appendix II B, at the maximum at 233 nm and calculate the content of C18H28N2O4 in the tablets taking 643 as the value of A (1%, 1 cm) at the maximum at 233 nm.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of Acebutolol.