Tablets contain the following Active Ingredients:
Paracetamol 250mg
Ibuprofen 200mg
Dissolution Condition:
Medium : Phosphate buffer pH 7.2 ; 900 mL
Apparatus : II ( Paddles )
Speed : 50 RPM
Temperature : 37°C ± 0.5°C
Time : 45 minutes.
Standard Preparation:
Transfer 110mg Paracetamol and 85 mg Ibuprofen secondary reference standard to 100 ml volumetric flask, add 70 ml of mobile phase, sonicate to dissolve and make up to volume with same. Further dilute 1 ml of above solution in 50 ml with dissolution media.
Sample Preparation:
Transfer 900ml of medium into each of the vessels of the dissolution apparatus. Let the temperature stabilize at 37°C ± 0.5°C and speed at 50rpm. Take randomly six tablets, and introduce one tablet in each of the vessels, start the apparatus. Stop the instruments after 45 minutes. Withdraw from each of the vessels about 10ml and dilute 2ml of this solution to 25ml with dissolution media.
Chromatography Condition:
Column : 150 × 4.6 mm, 5µm C18
Detector : 225nm
Injection volume : 20µl
Flow rate : 1.5 ml/ minute
Column temperature : 40ºC
Mobile phase : Buffer: Acetonitrile (50 : 50)
Buffer Preparation:
Dissolve 3ml of phosphoric acid in to 220ml of water.
System suitability:
The % RSD for five replicate injection of standard preparation should NMT 2.0 %
Procedure:
Inject standard preparation in five replicate and record the chromatogram. It should comply with the system suitability criteria as mention above. Inject sample preparation for each tablet and record the chromatogram, calculate the percent of dissolution by using the following formula:
Calculation:
Calculate the percentage of labeled amount dissolved:
Where,
At = Area of Sample solution
As = Average Area of Standard solution
Ws = Weight of Standard
L = Label claim
V = Volume of medium
P = Potency of Standard
Limit: Not less than 75% of the labelled amount dissolved in 45min.
NOTE: Analysts have to perform Method Validation as per Regulatory Guidelines.
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