Acebutolol Capsules
Action and use
Beta-adrenoceptor antagonist.
Definition
Acebutolol Capsules 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 contents of the capsules in potassium chloride, 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.
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
To a quantity of the mixed contents of 20 capsules containing the equivalent of 0.15 g of Acebutolol add 150 mL of water, shake for 10 minutes, add sufficient water to produce 250 mL, centrifuge and dilute 10 mL of the supernatant liquid to 100 mL with water. To 10 mL of this solution add 10 mL of 0.1m hydrochloric acid and sufficient water to produce 100 mL. Measure the absorbance of this solution, Appendix II B, at the maximum at 233 nm and calculate the content of C18H28N2O4 in the capsules taking 643 as the value of A(1%, 1 cm) at the maximum at 233 nm.
Storage
Acebutolol Capsules should be protected from light.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of acebutolol.