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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