- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Ibuprofen Oral Suspension |
Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.
Ibuprofen Oral Suspension is a suspension of Ibuprofen in a suitable flavoured vehicle.
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.
95.0 to 105.0% of the stated amount.
A. Shake a quantity of the oral suspension containing 0.5 g of Ibuprofen with 20 mL of chloroform, allow to stand until the layers have separated, filter and evaporate the filtrate to dryness in a current of air without heating. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ibuprofen (RS 186).
B. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Dilute a quantity of the oral suspension containing 0.1 g of Ibuprofen to 100 mL with absolute ethanol, shake vigorously for 5 minutes, filter (Whatman GF/C paper is suitable) and use the filtrate.
(2) 0.1% w/v of ibuprofen BPCRS in absolute ethanol.
(a) Use as the coating silica gel H.
(b) Use the mobile phase as described below.
(c) Apply 10 µL of each solution.
(d) Develop the plate to 10 cm.
(e) After removal of the plate dry it at 120° for 30 minutes, lightly spray the plate with a 1% w/v solution of potassium permanganate in 1m sulfuric acid, heat at 120° for 20 minutes and examine under ultraviolet light (365 nm).
1 volume of anhydrous acetic acid, 5 volumes of ethyl acetate and 15 volumes of n-hexane.
The principal spot in the chromatogram obtained with solution (1) corresponds in position, size and colour to that in the chromatogram obtained with solution (2). Disregard any spot remaining on the line of application.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions immediately after preparation.
(1) Mix a quantity of the oral suspension containing 0.2 g of Ibuprofen with 30 mL of acetonitrile, add a further 10 mL of acetonitrile and 10 mL of 0.01m orthophosphoric acid, shake vigorously, dilute to 100 mL with 0.01m orthophosphoric acid and filter (Whatman GF/C paper is suitable).
(2) 0.0006% w/v of 4′-isobutylacetophenone BPCRS in acetonitrile.
(3) 0.0006% w/v of 4′-isobutylacetophenone BPCRS and 0.2% w/v of ibuprofen BPCRS in the mobile phase.
The chromatographic conditions described under Assay may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to ibuprofen and 4′-isobutylacetophenone is at least 1.0.
In the chromatogram obtained with solution (1) the area of any peak corresponding to 4′-isobutylacetophenone is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions immediately after preparation.
(1) Mix a quantity of the oral suspension containing 0.1 g of Ibuprofen with 30 mL of acetonitrile, add a further 10 mL of acetonitrile and 10 mL of 0.01m orthophosphoric acid, shake vigorously, dilute to 100 mL with 0.01m orthophosphoric acid and filter (Whatman GF/C paper is suitable).
(2) 0.1% w/v of ibuprofen BPCRS prepared by dissolving a suitable quantity in 40 volumes of acetonitrile and adding 60 volumes of 0.01m orthophosphoric acid.
(a) Use a stainless steel column (30 cm × 3.9 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (µBondapak C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 220 nm.
(f) Inject 10 µL of each solution.
400 volumes of acetonitrile and 600 volumes of 0.01m orthophosphoric acid.
Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C13H18O2, weight in volume, from the declared content of C13H18O2 in ibuprofen BPCRS.
Ibuprofen Oral Suspension should be protected from light.
The impurities limited by the requirements of this monograph include:
1. 4′-isobutylacetophenone; 1-[4-(2-methylpropyl)phenyl]ethanone) (Ibuprofen Impurity E).