Determination of Atorvastatin(5/10/20/40mg) in tablet dosage form

1.0 OBJECTIVE                    

To provide the procedure for the determination of Atorvastatin in tablet dosage form

2.0 SCOPE

This procedure is Applicable to the determination of Atorvastatin in tablet dosage form

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

Atorvastatin calcium IP 

Equivalent to Atorvastatin   5/10/20/40mg

5.2 Assay Method: 

5.21 Preparation of standard solution:

Dissolve 10mg of the Atorvastatin calcium in 50ml of methanol and further diluted to 100ml with methanol.

Further dilute 1ml of the above solution into 10ml with methanol.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to10mg Atorvastatin calcium was accurately weighed, dissolved in 100 ml of methanol, filtered through Whatmann filter paper No: 41.

Further dilute 1ml of the above solution into 10ml with methanol.

5.2.3 Measure the absorbance at about 245nm

5.2.4 Calculate the content by comparison.

Sample absorbance    x  Standard weight  x Assay x 1xAverage weight of the tablet = 

Standard absorbance  x  Sample Weight   x   100  x1.085   

= ____________x100

         LC 

LC: Label Claim

6.0 ANNEXURES

Nil