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
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