| Parameter |
UPLC method Authentic sample Spiked plasma |
Derivative synchronous spectroscopy FDSFS |
| Linearity range μg /ml |
0.1-35 |
0.1- 4 |
1-12 |
| Regression data: |
| n |
7 |
7 |
7 |
| Slope ( b) |
115.12 |
2.01 |
0.298 |
| SD of slope |
0.65 |
0.014 |
0.71 |
| Intercept ( a ) |
-12.328 |
0.0158 |
0.3122 |
| SD of intercept |
0.92 |
0.02 |
0.03 |
| Correlation coefficient r |
0.9998 |
0.9998 |
0.9978 |
| Standard error SE % |
0.35 |
2.23 |
0.011 |
Recovery ± SD %
Drug substance
Drug product
Added standard |
98.55 ± 0.78
99.75 ± 0.93
99.98 ± 0.83 |
95.6 0 ± 5.70
94.33 ± 7.40 |
98.32 ± 0.66
98.66 ± 0.86
99.11 ± 0.71 |
Precision ± RSD %
Intra – day
Inter – day |
98.80 ± 0.56
100.1 ± 0.39 |
100.60 ± 3.90
103.2 ± 5.30 |
98.75 ± 0.75
98.82 ± 0.65 |
| LOD μg /ml |
0.03 |
0.03 |
0.33 |
| LOQ μg /ml |
0.10 |
0.10 |
1 |
Y=a+b C, where C is the concentration of the drug in μg/ml and Y is the peak ratio
of drug/I.S for the UPLC method or fluorescence intensity for fluorometric method.