Determination of eplerenone tablet (25/50mg) by UV Spectrophometric method

1.0 OBJECTIVE                    

To provide the procedure for the determination of eplerenone tablet (25/50mg) by UV Spectrophometric method.

2.0 SCOPE

This procedure is Applicable to the determination of eplerenone tablet (25/50mg) by UV Spectrophometric method

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:

Eplerenone   IP ………25/50mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 100mg of Eplerenone in methanol, with using ultra sonic devise for dissolving the compound and diluting to 100mL in a volumetric flask.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 100mg was accurately weighed, dissolved in 25ml of methanol, filtered through Whatmann filter paper No: 41 further diluted to 100ml with methanol.

5.2.3 Preparation of 2,4 dinitrophenylhydrazine (DNPH)

Dissolve 2.0gm of DNPH in 0.1M H2SO4

5.2.4 Preparation of Final Standard Solution

In a 10 mL volumetric flask, 1ml of standard solution, add 2 ml of freshly prepared solution DNPH and kept aside for colour development then adjust the volume with deionized water.

5.2.5 Prepare the Sample Solution as per 5.2.3

5.2.6 Measure the absorbance at about 430nm after 15 minutes of sample and standard Preparation.

5.2.7 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