1.0 OBJECTIVE
To provide the procedure for the determination of Ondansetron hydrochloride
tablets(4mg) by HPLC method
2.0 SCOPE
This procedure is Applicable to the determination of Ondansetron hydrochloride tablets(4mg)
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 Acetonitrile and 50 Volumes of methanol.
5.2 Standard and sample Preparation:
Weigh accurately about 100mg of Ondansetron hydrochloride working standards
in a 100ml volumetric flask and dissolve and dilute to 100 ml with mobile Phase.
Dilute 1ml of the above solution in to 10 ml with dilute with mobile
phase upto the mark.
5.3 Sample Preparation:
Weight powder twenty tablets and take the powder equivalent to
100mg Ondansetron hydrochloride was accurately weighed, dissolve dilute to
100ml with mobile Phase, filtered through Whatmann filter paper No: 41.
Dilute 1ml of the above solution in to 10 ml with dilute with mobile
phase upto the mark.
5.4 Chromatographic conditions:
Mode |
Isocratic |
Flow
rate |
1.2ml /
minute |
Wavelength
|
216nm |
Injection
volume |
20µL |
Column |
C18,
250*4.6*5µm |
Run
Time |
10
minutes |
5.5 Retention Time:
Ondansetron hydrochloride: 2.64 min
6.0 ANNEXURES
Nil
0 Comments