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
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