Propranolol Tablets

General Notices

Action and use

Beta-adrenoceptor antagonist.

Definition

Propranolol Tablets contain Propranolol Hydrochloride.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of propranolol hydrochloride, C16H21NO2,HCl

92.5 to 107.5% of the stated amount.

Identification

A. Suspend a quantity of the powdered tablets containing 0.1 g of Propranolol Hydrochloride in 20 mL of water, filter, make the filtrate alkaline with 1m sodium hydroxide and extract with three 10-mL quantities of ether. Wash the combined extracts with water until the washings are free from alkali, dry with anhydrous sodium sulfate, filter, evaporate the filtrate to dryness and dry the residue at 50° at a pressure of 2 kPa for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of propranolol (RS 298).
B. The light absorption of the solution obtained in the Assay, Appendix II B, exhibits two maxima, at 290 nm and 319 nm, and a shoulder at 306 nm.
C. Melting point of the residue obtained in test A, about 94°, Appendix V A.

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.

(1) Add 100 mL of methanol to a quantity of the powdered tablets containing 0.1 g of Propranolol Hydrochloride, shake, filter through glass-microfibre paper (Whatman GF/C is suitable) and use the filtrate.
(2) Dilute 1 volume of solution (1) to 500 volumes.
(3) 0.1% w/v of propranolol hydrochloride for performance test EPCRS.
chromatographic conditions
(a) Use a stainless steel column (20 cm × 5 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS 5µm is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.8 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 292 nm.
(f) Inject 10 µL of each solution.
(g) Allow the chromatography to proceed for five times the retention time of the principal peak.
mobile phase

A mixture of 1.15 g of sodium dodecyl sulfate, 10 mL of a mixture of 1 volume of sulfuric acid and 9 volumes of water, 20 mL of a 1.7% w/v solution of tetrabutylammonium dihydrogen orthophosphate, 370 mL of water and 600 mL of acetonitrile.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), baseline separation is achieved between the peaks due to impurity A and propranolol.

limits

In the chromatogram obtained with solution (1):

the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);

the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (0.8%).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powder containing 20 mg of Propranolol Hydrochloride with 20 mL of water for 10 minutes. Add 50 mL of methanol, shake for a further 10 minutes, add sufficient methanol to produce 100 mL and filter. Dilute 10 mL of the filtrate to 50 mL with methanol and measure the absorbance of the resulting solution at the maximum at 290 nm, Appendix II B. Calculate the content of C16H21NO2,HCl taking 206 as the value of A(1%, 1 cm) at the maximum at 290 nm.