1.0 OBJECTIVE
To provide the procedure
for the determination
of Alprazolam (0.25/0.5/1mg)
2.0 SCOPE
This procedure is
Applicable to the determination
of Alprazolam (0.25/0.5/1mg)
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:
Alprazolam IP 0.25/0.50/1mg
5.2 Assay Method:
5.21 Preparation of
standard solution:
Dissolve 100mg of the Alprazolam in 50ml of 0.1N hydrochloric acid and further diluted to 100ml with 0.1N hydrochloric acid.
Further dilute 1ml of the above solution into 10ml with methanol.
5.2.2 Preparation of
Sample solution:
Weight powder twenty tablets and take the powder equivalent to100mg Alprazolam was accurately weighed, dissolved in 100 ml of 0.1N hydrochloric acid, filtered through Whatmann filter paper No: 41.
Further dilute 1ml of the above solution into 10ml with methanol.
5.2.3 Measure the absorbance at about 260nm
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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