Table 2 Validation parameters of RP-HPLC method for TAP
Parameters | Values a± SD, ± %RSD |
|---|---|
Linearity | 0.2 to 2 μg/ml |
Regression equation | AUC = 18,374.93× -62.59 |
Correlation coefficient | r2 = 0.9998 ± 0.001, ± 0.100 |
Response ratio | 2,377.778 ± 1.510, ± 0.063 |
Range | 0.8 to 1.6 μg/ml ± 1.23, ± 0.02 |
Accuracy | 100.05 ± 0.841, ± 0.841 |
Precision | |
Repeatability | 100.07 ± 0.319, ± 0.319 |
Intermediate precision | |
Inter-day | 99.89 ± 0.205, ± 0.205 |
Analyst to analyst | 99.74 ± 0.125, ± 0.125 |
Robustness | |
Temperature (20°C, 25°C, 30°C) | 100.21 ± 0.75, ± 0.748 |
Formic acid concentration (±5%) | 100.12 ± 0.54, ± 0.539 |
LOQ | 8 ng/ml ± 0.93, ± 0.063 |
LOD | 1 ng/ml ± 0.78, ± 0.067 |
Specificity | Ascertained by analyzing standard drug and samples of equivalent concentration |
Stability in sample solution | |
Response ratio | 184.16 ± 1.83, ± 0.057 |