1.0 OBJECTIVE
To provide the procedure for the determination of Candesartan cilexetil tablets(4/8/16/32mg)
2.0 SCOPE
This procedure is Applicable to the determination of Candesartan cilexetil tablets(4/8/16/32mg)
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 Tablet Contains:
Candesartan cilexetil IP 4/8/16/32mg
5.2 Assay Method:
5.21 Preparation of
standard solution:
Dissolve 100mg of the candesartan cilexetil in 50ml of methanol and further diluted to 100ml with methanol.
Further dilute 5ml of the above solution into 100ml with methanol.
5.2.2 Preparation of
Sample solution:
Weight powder twenty tablets and take the powder equivalent to100mg candesartan cilexetil was accurately weighed, dissolved in 100 ml of methanol, filtered through Whatmann filter paper No: 41. Further dilute 5 ml of the above solution into 100 ml with methanol.
5.2.3 Measure the absorbance at about 258 nm
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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