Estimation of Letrozole (2.5/5mg) tablets by HPLC method

1.0 OBJECTIVE                    

To provide the procedure for the determination of Letrozole (2.5/5mg) tablets by HPLC method.

2.0 SCOPE

This procedure is Applicable to the determination of Letrozole (2.5/5mg) tablets by HPLC Method.

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 Mobile Phase:

50 Volumes of water and 50 Volumes of acetonitrile

5.2 Standard and sample Preparation:

Weigh accurately about 50mg of Letrozole working standards in a 50ml volumetric flask and dissolve and dilute with mobile Phase.

Dilute 2ml of the above solution in to 100 ml with dilute with mobile phase upto the mark.

5.3 Sample Preparation:

Weight powder twenty tablets and take the powder equivalent to 50mg Letrozole was accurately weighed, dissolved in 50ml of mobile Phase, filtered through Whatmann filter paper No: 41.

Dilute 2ml of the above solution in to 100 ml with dilute with mobile phase upto the mark.

5.4 Chromatographic conditions:

Mode                          

Isocratic

Flow rate                    

1.0 ml / minute

Wavelength               

265nm

Injection volume        

20µL

Column                      

C18, 250*4.6*5µm

Run Time

10 minutes

 5.5 Retention Time:

Letrozole: 4.8 min

6.0 ANNEXURES

Nil

 

 

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