Estimation of Aripiprazole (2/5/10/15/20/30mg) in tablet formulation

 1.0 OBJECTIVE                    

To provide the procedure for the determination of Aripiprazole (2/5/10/15/20/30mg)

2.0 SCOPE

This procedure is Applicable to the determination of Aripiprazole (2/5/10/15/20/30mg)

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:

Aripiprazole   IP 2/5/10/15/20/30mg

5.2 Assay Method: 

5.21 Preparation of standard solution:

Dissolve 50mg of the  Aripiprazole in 25 ml of methanol and further diluted to 50 ml with methanol.

Further dilute 10 ml of the above solution into 100 ml with methanol

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 50mg of Aripiprazole was accurately weighed, dissolved in 50ml of methanol, filtered through Whatmann filter paper No: 41. Further dilute 10 ml of the above solution into 100 ml with methanol.

5.2.3 Measure the absorbance at about 219 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