Determination of Febuxostat tablets (40/80mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for the determination of Febuxostat tablets (40/80mg)

2.0 SCOPE

This procedure is Applicable to the determination of Febuxostat tablets (40/80mg)

3.0 RESPONSIBILITY 

3.1 QC-Chemist 

4.0 ACCOUNTABILITY         

4.1 Executive – Quality control

4.2 Head – Quality control

5.0 PROCEDURE      

 5.1 Label Claim: 

Each film coated tablet Contains:

Febuxostat IP ……………….40/80mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 50mg of the Febuxostat in 25ml of methanol water and further diluted to 50ml with methanol. Further dilute 1ml of the above solution into 100ml with methanol.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 50mg in methanol was accurately weighed, dissolved in 25ml of methanol, filtered through Whatmann filter paper No: 41 further diluted to 50ml with methanol.

Further dilute 1ml of the above solution into 100ml with methanol

5.2.3 Measure the absorbance at about 315nm

5.2.4 Calculate the content by comparison.

Sample absorbance    x  Standard weight  x Assay x Average weight of the tablet = 

Standard absorbance  x  Sample Weight   x   100     

= ____________x100

         LC 

LC: Label Claim

6.0 ANNEXURES

Nil