Estimation of Alprazolam (0.25/0.5/1mg) in tablet formulation

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