Version: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Beta-adrenergic receptor antagonist.
DEFINITION
Acebutolol capsules contain Acebutolol Hydrochloride.
The capsules comply with the requirements given in the section Capsules and the following requirements.
Acebutolol content, C 18 H 28 N 2 O 4
95.0 to 105.0% of the stated amount.
IDENTIFICATION
The infrared absorption spectrum of a 0.7% w/w dispersion of the capsule contents in potassium chloride, Annex II A, was consistent with the reference spectrum of Acebutolol hydrochloride (RS 380).
CHECK
Related substances
Perform thin layer chromatography, Appendix III A, using the following solutions.
(1) Add to the contents of a capsule containing the equivalent of 0.4 g Acebutolol 20 mL of an equal volume mixture of chloroform and methanol, shake for 2 minutes, centrifuge, and use the supernatant.
(2) Dilute 3 volumes of solution (1) to 100 volumes with a mixture of equal volumes of chloroform and methanol and further dilute 1 volume of this solution to 10 volumes with the same solvent mixture.
(3) Dilute 1 volume of solution (1) to 100 volumes with a mixture of equal volumes of chloroform and methanol and further dilute 1 volume of this solution to 10 volumes with the same solvent mixture.
CHROMATOGRAPHIC CONDITIONS
(a) Use a pre-coated F254 silica gel plate (Merck F254 silica gel 60 plates are suitable).
(b) Use the mobile phase as described below.
(c) Add 10 μL of each solution.
(d) Develop the plate to 15 cm.
(e) After removing the plate, allow it to air dry and examine under UV light (254 nm).
MOBILE PHASE
20 volumes of glacial acetic acid, 20 volumes of dimethylformamide and 60 volumes of chloroform.
LIMIT
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%).
Discard any remaining residue on the smear.
TESTING
Take a mixture of 20 capsules containing the equivalent of 0.15 g Acebutolol, add 150 mL of water,
shake for 10 minutes, add enough water to make 250 mL, centrifuge and dilute 10 mL of the supernatant to
100 mL with water. Take 10 mL of this solution, add 10 mL of 0.1 M hydrochloric acid solution and enough water to make 100 mL.
Measure the absorbance of this solution, Appendix II B, at the maximum wavelength of 233 nm and calculate the content of C 18 H 28 N 2 O 4 in the capsule, taking 643 as the value A (1%, 1 cm) at the maximum wavelength of 233 nm .
TREAT
Acebutolol capsules must be protected from light.
LABELING
The amount of active ingredient is stated in terms of acebutolol equivalents.
