1.0 OBJECTIVE
To provide the procedure
for the determination of Amiodarone
hydrochloride tablets (100/200mg)
2.0 SCOPE
This procedure is
Applicable to the determination of Amiodarone
hydrochloride tablets (100/200mg)
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 uncoated tablet Contains:
Amiodarone hydrochloride IP ---- 100/200mg
5.2 Assay Method:
5.2.1 Solvent
Preparation
Methanol: water (60:40v/v)
5.21 Preparation of
standard solution:
Dissolve 10mg of the Amiodarone hydrochloride in 50ml of solvent
and further diluted to 100ml with solvent. Further dilute 0.8ml of the above
solution into 10ml with solvent.
5.2.2 Preparation of
Sample solution:
Weight powder twenty
tablets and take the powder equivalent to10mg Amiodarone hydrochloride was accurately weighed, dissolved in 100
ml of solvent, filtered through Whatmann filter paper No: 41.
Further dilute 0.8ml of
the above solution into 10ml with solvent.
5.2.3 Measure the absorbance at about 242 nm
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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