Estimation of Daunorubicin Injection (20mg/4ml) by HPLC method

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