Acebutolol Capsules

General Notices

Action and use

Beta-adrenoceptor antagonist.

Definition

Acebutolol Capsules contain Acebutolol Hydrochloride.

The capsules comply with the requirements stated under Capsules and with the following requirements.

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.

(1) Add to a quantity of the contents of the capsules containing the equivalent of 0.4 g of Acebutolol 20 mL of a mixture of equal volumes of chloroform and methanol, shake for 2 minutes, centrifuge and use the supernatant liquid.
(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 mixture of solvents.
(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 mixture of solvents.
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, 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

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.