Paediatric Paracetamol Oral Solution

Analgesic; antipyretic.

Paediatric Paracetamol Oral Solution is a solution containing 2.4% w/v of Paracetamol in a suitable flavoured vehicle.

It should not be diluted.

The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.

2.28 to 2.52% w/v.

A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1) Dilute the preparation being examined with methanol 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 reveal the spots using Method 1.

0.5 volume of glacial acetic acid, 10 volumes of toluene, 25 volumes of acetone and 65 volumes of chloroform.

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 (2) shows a peak with the same retention time as the peak due to paracetamol in the chromatogram obtained with solution (1).

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

(1) Shake 5 mL of the preparation being examined with 15 mL of the mobile phase, dilute to 25 mL with the mobile phase and filter if necessary.

(2) 0.0024% w/v of 4-aminophenol in the mobile phase.

(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil ODS is suitable).

(b) Use isocratic elution using the mobile phase described below.

(c) Use a flow rate of 2.0 mL per minute.

(d) Use an ambient column temperature.

(e) Use a detection wavelength of 272 nm.

(f) Inject 20 µL of each solution.

0.01m sodium butanesulfonate in a mixture of 0.4 volumes of formic acid, 15 volumes of methanol and 85 volumes of water.

In the chromatogram obtained with solution (1):

the area of any peak corresponding to 4-aminophenol is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.5%).

Peaks with a long retention time may occur due to preservatives in the preparation.

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 procedure may be carried out using the conditions described in the test for 4-Aminophenol but using a detection wavelength of 243 nm.

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.

Paediatric Paracetamol Oral Solution should be protected from light. It should not be refrigerated.