Validation Parameters
Ethinyl estradiol
Drospirenone
Mobile Phase
70:30 (Ammonium Acetate: ACN)
70:30 (Ammonium Acetate: ACN)
Flow Rate
1 ml/min
1 ml/min
Detection wave Length
PDA at 258 nm
PDA at 258 nm
Rt
1.438
5.321
Run Time
7 min
7 min
Asymmetry
1.693
1.188
Theoretical Plates
3636
7728
LOD
0.00026 ppm
0.0925 ppm
LOQ
0.00087 ppm
0.308 ppm
Linearity
R2=0.998
R2=0.999
Precision
% RSD < 2
% RSD < 2
Recovery
99-101%
98-102%
Table 7:
System suitability parameters for HPLC.