Determination of Indomethacin capsules(25mg)

1.0 OBJECTIVE                    

To provide the procedure for the determination of Indomethacin capsules(25mg)

2.0 SCOPE

This procedure is Applicable to the determination of Indomethacin capsules(25mg)

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 hard gelatin capsule Contains:

Indomethacin IP ……………….25mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 50mg of the Indomethacin in 25ml of 0.1N KOH and further diluted to 50ml with 0.1N KOH. Further dilute 1ml of the above solution into 100ml with 0.1N KOH.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 50mg in methanol was accurately weighed, dissolved in 25ml of 0.1N KOH, filtered through Whatmann filter paper No: 41 further diluted to 50ml with 0.1N KOH.

Further dilute 1ml of the above solution into 100ml with 0.1N KOH.

5.2.3 Measure the absorbance at about 228nm

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