- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Paediatric Paracetamol Oral Suspension |
Analgesic; antipyretic.
Paediatric Paracetamol Oral Suspension is a suspension containing not more than 5% w/v of Paracetamol in a suitably flavoured vehicle. It should not be diluted.
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. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Dilute the preparation being examined with methanol and shake to produce a solution containing 0.24% w/v of Paracetamol and filter if necessary.
(2) 0.24% w/v of paracetamol BPCRS in methanol.
(a) Use as the coating silica gel F254.
(b) Use the mobile phase described below.
(c) Apply 10 µL of each solution.
(d) Develop to 15 cm.
(e) After removal of the plate, dry in a current of warm air, examine under ultraviolet light (254 nm) and also reveal the spots using Method 1.
0.5 of a volume of glacial acetic acid, 10 volumes of toluene, 25 volumes of acetone and 65 volumes of dichloromethane.
By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to paracetamol in the chromatogram obtained with solution (2).
Carry out the method for liquid chromatography, Appendix III D. Prepare the solutions immediately before use and protect from light.
(1) Shake 5 mL of the preparation being examined with 4 mL of the mobile phase, dilute with the mobile phase to contain 0.12% w/v of Paracetamol and filter if necessary.
(2) Dilute 1 volume of solution (1) to 100 volumes with the mobile phase and dilute 1 volume of the resulting solution to 10 volumes with the mobile phase.
(3) 0.00012% w/v each of 4-aminophenol and paracetamol BPCRS in the mobile phase.
(4) Dilute a 0.0012% w/v solution of 4′-chloroacetanilide in methanol with the mobile phase to produce a solution containing 0.0000012% w/v of 4′-chloroacetanilide.
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octylsilyl silica gel for chromatography (5 µm) (Zorbax Rx C8 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use a column temperature of 35°.
(e) Use a detection wavelength of 245 nm.
(f) Inject 50 µL of each solution.
(g) For solution (1), allow the chromatography to proceed for 12 times the retention time of the principal peak.
250 volumes of methanol containing 1.15 g of a 40% w/v solution of tetrabutylammonium hydroxide, 375 volumes of 0.05m disodium hydrogen orthophosphate and 375 volumes of 0.05m sodium dihydrogen orthophosphate.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 4.0.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to 4-aminophenol is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.1%);
the area of any peak corresponding to 4′-chloroacetanilide is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (10 ppm);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);
the sum of the areas of any other secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).
Disregard any peak with an area less than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.03%).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Mix a weighed quantity of the preparation being examined containing 24 mg of Paracetamol with 100 mL of the mobile phase, dilute to 200 mL with the mobile phase and filter if necessary.
(2) 0.012% w/v of paracetamol BPCRS in the mobile phase.
The chromatographic conditions described under Related substances test may be used.
Determine the weight per mL of the preparation, Appendix V G, and calculate the percentage content of C8H9NO2, weight in volume, using the declared content of C8H9NO2 in paracetamol BPCRS.