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
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
0 Comments