BP 2025 (Ph. Eur. Update 11.6)
Action and use
Beta-adrenergic specific antibiotic.
DEFINITION
Acebutolol tablets contain Acebutolol Hydrochloride.
These medicinal products comply with the requirements stated in the medicinal product 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 powdered tablets in potassium bromide, Annex II A, was consistent with the common reference 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.
(1) A quantity of the powdered tablets containing the equivalent of 0.4 g of Acebutolol in 20 mL of the solvent mixture, shaken for 2 minutes and centrifuged. Use the supernatant liquid.
(2) Dilute 3 volumes of solution (1) to 100 volumes with the solvent mixture. Further dilute 1 volume of the resulting solution to 10 volumes with the solvent mixture.
(3) Dilute 1 volume of solution (1) to 100 volumes with the solvent mixture. Further dilute 1 volume of the resulting solution to 10 volumes with the solvent mixture.
CHROMATOGRAPHIC CONDITIONS
(a) Use a precoated silica gel F254 plate (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 10 μL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm).
MOBILE PHASE
20 volumes of glacial acetic acid, 20 volumes of dimethylformamide and 60 volumes of chloroform.
LIMITS
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.
