Estimation of Deflazacort tablets (6/12/18/24/30mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for the determination of Deflazacort tablets (6/12/18/24/30mg)

2.0 SCOPE

This procedure is Applicable to the determination of Deflazacort tablets (6/12/18/24/30mg)

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:

Deflazacort    IP ……………….6/12/18/24/30mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 100mg of the Deflazacort in 50ml of methanol water and further diluted to 100ml with methanol. 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 to 100mg in methanol was accurately weighed, dissolved in 50 ml of methanol, filtered through Whatmann filter paper No: 41 further diluted to 100ml with methanol.

Further dilute 1ml of the above solution into 10ml with methanol

5.2.3 Measure the absorbance at about 244nm

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