Estimation of Eplerenon tablets (25/50mg)

1.0 OBJECTIVE                    

To provide the procedure for the determination of Eplerenon tablets (25/50mg)

2.0 SCOPE

This procedure is Applicable to the determination of Eplerenon tablets (25/50mg)

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:

Eplerenon  IP ……………….25/50mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 50mg of the Eplerenon  in 40ml of methanol and further diluted to 50ml with double distilled water. Further dilute 10ml of the above solution into 100ml with methanol : water(80:20).

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 50mg Eplerenon  was accurately weighed, dissolved in 40 ml of methanol, filtered through Whatmann filter paper No: 41 further diluted to 50ml with double distilled water.

Further dilute 10ml of the above solution into 100ml with methanol : water (80:20).

5.2.3 Measure the absorbance at about 242.5nm

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