Estimation of Amiodarone hydrochloride tablets (100/200mg)

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