Estimation of Anastrozole (1mg) in tablet formulation

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