1.0 OBJECTIVE
To provide the procedure
for the determination
of Daunorubicin (20mg/4ml)
2.0 SCOPE
This procedure is
Applicable to the determination
of Daunorubicin (20mg/4ml)
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:
25 Volumes of methanol and 75
Volumes of acetonitrile
5.2 Standard
and sample Preparation:
Weigh accurately about 10mg of Daunorubicin working
standards in a 10ml volumetric flask and dissolve and dilute 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:
Weigh accurately about 10mg equivalent of injection in a 10ml
volumetric flask and dissolve and dilute with mobile Phase.
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 |
1.0 ml / minute |
Wavelength
|
228nm |
Injection
volume |
20µL |
Column |
C18, 250*4.6*5µm |
Run Time |
10 minutes |
5.5 Retention Time:
Daunorubicin: 4.5 min
6.0 ANNEXURES
Nil
0 Comments