PROCEDURE of Paracetamol Infusion
1.1 Sampling and Handling
1.1.1 Quantity of Composite Sample for Analysis
100 ml in well closed Container
1.1.2 Quantity of Reserve Sample of Paracetamol Infusion
100 ml in well closed container
1.1.3 Label Claim
Each 100ml Contains
Paracetamol IP…………1000 mg
Mannitol IP………..…..…5.0% w/v
Water for Injections IP….q.s.
1.2 Test and Method
1.2.1 Description: A clear colourless solution.
1.2.2 pH
Measure the pH value of undiluted soln. at 25°C on suitable calibrated pH meter.
Limit: 5.8 to 6.2
1.2.3 Assay:
Paracetamol (By UV)
Take 15.0 ml of soln. of Paracetamol infusion sample , add 50.0 ml of 0.l M sodium hydroxide, dilute with 100 ml of water, shake for 15 minutes and add sufficient water to produce 200.0 ml. Mixed and dilute 10.0 millilitre of above soln. to 100.0 ml with water. To 10.0 ml of the resulting solution add 10 ml of 0.1 M sodium hydroxide, dilute to 100.0 ml with water and mixed. Measure the absorbance of the resulting soln. at the maximum at about 257 nm. Calculate the content of Paracetamol taking 715 as the specific absorbance at 257 nm.
Calculation:
Rt X 200 X 100 X 100 / (715 X 15 X 10 X 10 X 1000)
=………….……mg/100 ml
Where:
P = Specified purity of Paracetamol WS.
Rs = Area of the major peak obtained from Reference solution.
Rt = Area of the major peak obtained from Test solution.
WS = Weight of Paracetamol working standard in mg.
Mannitol: (By Titration Method)
Procedure:
Dilute an accurately measured volume equivalent to 0.4 g (about 8ml ) of Mannitol to 100.0 ml with water, transfer 10.0 ml to a stoppered flask, add 20.0 ml of 0.1M Sodium Periodate and 2 ml of 1M Sulphuric acid and heat on a water-bath for 15 minutes. Cool, add 3 g of Sodium Bicarbonate, in small quantities, and 25.0 ml of 0.1M Sodium Arsenite, mix, add 5 ml of a 20% w/v solution of Potassium Iodide and allow to stand for 15 minutes. Titrate with 0.05M iodine until the first trace of yellow colour appears. Repeat the operations without the substance being examined. The difference between the titrations represents the amounts of iodine required.
Each ml of 0.05M Iodine is equivalent to 0.001822 g of C6H14O6.
Calculation:
Burette reading X Molarity of 0.05M Iodine X 0.001822 X 100 X 100 / ( 8 X 10.0 X 0.05)
= % wt. /vol.