Table 5 Validation results of proposed UHPLC method for the estimation of Tolvaptan
Parameters | TLP | Acceptable criteria |
|---|---|---|
Linearity | 0.999 | |
Concentration range (µg/mL) | 10–150 µg/mL | |
Slope | 49.22 | |
Intercept | 75.48 | |
Correlation coefficient (r) | 0.99916 | |
Accuracy (% recovery) | 98–102% ± 2.0% | |
50% mean ± RSD | 99.964 ± 0.397472 | |
100% mean ± RSD | 99.775 ± 0.590492 | |
150% mean ± RSD | 100.0793 ± 0.822959 | |
Precision | RSD (%) | NMT 2.0% |
Method precision | 0.4681 | |
System precision | 0.0482 | |
LoD | 0.00606 mg/mL | |
LoQ | 0.0183677 mg/mL | |
Robustness | RSD (%) | NMT 2.0% |
Flow 0.1 (mL/min) | 0.0251 | |
Flow 0.3 (mL/min) | 0.4941 | |
Mobile Phase_ACN:H2O (94:6) | 0.1072 | |
Mobile Phase_ACN:H2O (96:4) | 0.0819 | |
Temperature 30 °C | 0.0461 | |
Temperature 20°C | 0.2719 | |
Solution stability (5 days) | 0.31 | NMT 2.0% |