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Acebutolol Tablets | |
| Action and use | Beta-adrenoceptor antagonist. |
Definition | Acebutolol Tablets contain Acebutolol Hydrochloride. The tablets comply with the requirements stated under Tablets 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 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 a precoated silica gel F254 plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 20 volumes of glacial acetic acid, 20 volumes of dimethylformamide and 60 volumes of chloroform as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) add to a quantity of the powdered tablets 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. For solution (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. For solution (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. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.3%) and 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 the active ingredient is stated in terms of the equivalent amount of acebutolol. |
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