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Assay Method for Paracetamol & Ibuprofen Tablets

Tablets contains following Active Ingredients:
Paracetamol 250mg
Ibuprofen 200mg

Chromatographic Conditions: 
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 (30 : 70) 

Buffer Preparation: 
Dissolve 3ml of phosphoric acid in to 220ml of water. 

Preparation of Standard: 
Transfer 50mg Paracetamol and 40 mg Ibuprofen secondary reference standard to 50 ml volumetric flask, add 35 ml of mobile phase, sonicate to dissolve and make up to volume with same. Further dilute 1 ml of solution in 50 ml with mobile phase. 


Sample Preparation: 
Weigh and powder 20 tablets. Weigh accurately tablet powder equivalent to 50mg Paracetamol and transfer in to a 50 ml volumetric flask and add 35 ml of mobile phase, sonicate for 30 minutes, dilute up to the mark with same. Dilute 1ml of resulting solution to 50ml with mobile phase. 

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 in duplicate, record the chromatogram and calculate the percent of assay by using the following formula: 

Calculation: 


                    Where, 
                          At = Average area of Sample solution 
                          As = Average area of Standard solution 
                          Ws = Weight of Standard 
                          Wt = Weight of Sample 
                          ATW = Average Tablet Weight 
                          L = Label Claim 
                          P = Potency of Standard


NOTE: Analyst have to perform Method Validation as per Regulatory Guidelines.

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