1.0 OBJECTIVE
To provide the procedure
for the determination
of Anastrozole (1mg)
2.0 SCOPE
This procedure is
Applicable to the determination
of Anastrozole (1mg)
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 film coated tablet contains:
Anastrozole IP 1 mg
5.2 Assay Method:
5.21 Preparation of
standard solution:
Dissolve 50mg of the Anastrozole in 3 ml of the 1 N hydrochloric acid ( 1 N HCL) and further dilute with 100 ml with 1 N HCL.
Further dilute 1 ml of the above solution into 10 ml with 1 N HCl.
5.2.2 Preparation of Sample solution:
Weight powder twenty tablets and take the powder equivalent tog 50mg of Anastrozole was accurately weighed, dissolved in 100 ml of 1N HCl, filtered through Whatmann filter paper No: 41.
Further dilute 1 ml of the above solution into 10 ml with 1 N HCl.
5.2.3 Measure the absorbance at about 205.9nm
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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