1.0 OBJECTIVE
To provide the procedure for the determination of Captopril (25/50mg)
tablets by HPLC method
2.0 SCOPE
This procedure is Applicable to the determination of Captopril (25/50mg)
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:
80 Volumes of water, 10 volumes of Acetonitrile, 10 Volumes of
Tetrahydrofuran and 0.1 Volumes of methane Sulphonic acid. Adjust the pH of the
mobile Phase to 2.5.
5.2 Standard and sample Preparation:
Weigh accurately about 100mg of Captopril working standards in a 100ml
volumetric flask and dissolve with 60ml of methanol and dilute to 100 ml with
mobile Phase.
Dilute 5ml of the above solution in to 50 ml with dilute with mobile
phase upto the mark.
5.3 Sample Preparation:
Weight powder twenty tablets and take the powder equivalent to
100mg Captopril was accurately weighed, dissolved in 60ml of mobile Phase
and dilute to 100ml with mobile Phase, filtered through Whatmann filter
paper No: 41.
Dilute 5ml of the above solution in to 50 ml with dilute with mobile
phase upto the mark.
5.4 Chromatographic conditions:
Mode |
Isocratic |
Flow
rate |
1.0ml /
minute |
Wavelength
|
220nm |
Injection
volume |
20µL |
Column |
C8,
250*4.6*5µm |
Run
Time |
10 minutes |
5.5 Retention Time:
Captopril: 3.0 min
6.0 ANNEXURES
Nil
0 Comments