Propranolol Prolonged-release Capsules
Propranolol Hydrochloride Prolonged-release Capsules;Propranolol Hydrochloride Sustained-release Capsules; Propranolol Hydrochloride Extended-release Capsules
Propranolol Prolonged-release Capsules manufactured by different manufacturers, whilst complying with the requirements of the monograph, are not interchangeable, as the dissolution profile of the products of different manufactures may not be the same.
Propranolol Hydrochloride Prolonged-release Capsules contain not less than 92.5 per cent and not more than 107.5 per cent of the stated amount of propranolol hydrochloride, C16H21NO2,HCl.
Usual strengths.40 mg; 60 mg and 80 mg.
Identification
- When examined in the range 290 nm and 319 nm (2.4.7), the solution obtained in the Assay, shows absorption maximum and a shorter at 306 nm.
- Determine by thin layer chromatography (2.4.17), coating the plate withsilica gel GF254.
Mobile phase.A mixture of 1 volume of18 Mammonia and 99 volumes of methanol.
Test solution. Shake a quantity of the powdered capsules containing 20 mg of Propranolol Hydrochloride with 10 ml of methanol for 5 minutes and filter.
Reference solution .A 0.2 per cent w/v solution of propranolol hydrochloride RS in methanol.
Apply to the plate 10 µl of each solution. After development, dry the plate in air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with reference solution.
Tests
Dissolution (2.5.2).Complies with the test stated under Capsules.
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Disperse a quantity of the powdered capsules containing 0.1 g of Propranolol Hydrochloride with 100 ml of methanol sonicate for 15 minutes and filter.
Reference solution (a).Dilute 1.0 ml of the test solution to 500.0 ml with the mobile phase.
Reference solution (b).A 0.1 per cent w/v solution of propranolol hydrochloride RS for performance test in the mobile phase.
Chromatographic system
– a stainless steel column 20 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 µm) (Such as Hypersil ODS,5 µm),
– mobile phase: a mixture of 1.15 g of sodium dodecyl sulphate, 10 ml of a mixture of 1 ml of sulphuric acid and 9 ml of water, 20 ml of a 1.7 per cent w/v solution of tetrabutylammoniumdihydrogen orthophosphate, 370 ml of water and 600 ml of acetonitrile, the mixture adjusted to pH 3.3 with 2M sodium hydroxide,
– flow rate: 1.8 ml per minute,
– spectrophotometer set at 292 nm,
– injection volume: 10 µl.
To run the chromatogram for 5 times the retention time of principal peak.
Inject reference solution (b). The test is not valid unless the chromatogram obtained with reference solution (b) baseline sepration is achieved between the peaks due to impurity A [(2RS)-3-(naphthalene-1-yloxy) propane-1,2-diol] and propranolol.
Inject reference solutions (a), and the test solution. In the chromatogram obtained with the test solution the area of any secondary peak is not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent). The sum of the areas of any secondary peaks is not more than 4 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.8 per cent).
Other tests. Comply with the tests stated under Capsules.
Assay. Weigh a quantity of the mixed contents of 20 capsules containing about 80 mg of Propranolol Hydrochloride, add 150 ml of methanol, heat to boiling and boil for 2 minutes, remove from the heat, shake for 20 minutes, cool to20° and add sufficient methanol to produce 200.0 ml. Mix and filter, discard the first 20 ml of filtrate, and dilute 10.0 ml of the filtrate to 200.0 ml with methanol. Measure the absorbance of the resulting solution at the maximum at about 290 nm (2.4.7).
Calculate the content of C16H21NO2, HCl taking 206 as the specific absorbance at 290 nm.