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
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