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
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