Table 3 Parameters related to robustness evaluation
Drugs | Variable parameters | Degree of variation | Retention time | Tailing factor | Resolution |
|---|---|---|---|---|---|
ETO | Mobile phase ratio | Buffer 92% | 7.214 | 1.234 | 20.306 |
Buffer 93% | 7.275 | 1.280 | 20.296 | ||
Buffer 94% | 7.232 | 1.252 | 20.212 | ||
Mean ± SD | 7.240 ± 0.031 | 1.255 ± 0.023 | 20.271 ± 0.051 | ||
%RSD | 0.034 | 1.846 | 0.254 | ||
Flow Rate | 1.9 | 7.243 | 1.269 | 20.242 | |
2.0 | 7.275 | 1.280 | 20.296 | ||
2.1 | 7.253 | 1.250 | 20.215 | ||
Mean ± SD | 7.257 ± 0.016 | 1.266 ± 0.015 | 20.251 ± 0.033 | ||
%RSD | 0.225 | 1.198 | 0.166 | ||
pH | 3.8 | 7.253 | 1.278 | 20.272 | |
4.0 | 7.225 | 1.280 | 20.296 | ||
4.2 | 7.243 | 1.268 | 20.249 | ||
Mean ± SD | 7.257 ± 0.016 | 1.272 ± 0.006 | 20.272 ± 0.023 | ||
%RSD | 0.225 | 0.504 | 0.115 | ||
PCM | Mobile phase ratio | Buffer 92% | 3.379 | 1.350 | 12.368 |
Buffer 93% | 3.413 | 1.352 | 12.290 | ||
Buffer 94% | 3.381 | 1.354 | 12.375 | ||
Mean ± SD | 3.391 ± 0.019 | 1.352 ± 0.002 | 12.344 ± 0.047 | ||
%RSD | 0.562 | 0.147 | 0.382 | ||
Flow Rate | 1.9 | 3.403 | 1.302 | 12.310 | |
2.0 | 3.413 | 1.352 | 12.290 | ||
2.1 | 3.392 | 1.329 | 11.899 | ||
Mean ± SD | 3.402 ± 0.010 | 1.327 ± 0.025 | 12.166 ± 0.231 | ||
%RSD | 0.308 | 1.885 | 1.904 | ||
pH | 3.8 | 3.392 | 1.324 | 12.160 | |
4.0 | 3.413 | 1.352 | 12.290 | ||
4.2 | 3.318 | 1.338 | 11.887 | ||
Mean ± SD | 3.374 ± 0.049 | 1.338 ± 0.014 | 12.112 ± 0.205 | ||
%RSD | 1.478 | 1.046 | 1.698 | ||
PAP | Mobile phase ratio | Buffer 92% | 1.742 | 1.551 | |
Buffer 93% | 1.728 | 1.550 | – | ||
Buffer 94% | 1.779 | 1.552 | – | ||
Mean ± SD | 1.749 ± 0.026 | 1.551 ± 0.001 | |||
%RSD | 1.506 | 0.064 | |||
Flow Rate | 1.9 | 1.759 | 1.54 | – | |
2.0 | 1.728 | 1.55 | – | ||
2.1 | 1.700 | 1.497 | – | ||
Mean ± SD | 1.729 ± 0.029 | 1.529 ± 0.028 | |||
%RSD | 1.706 | 1.841 | |||
pH | 3.8 | 1.789 | 1.540 | – | |
4.0 | 1.728 | 1.550 | – | ||
4.2 | 1.789 | 1.590 | – | ||
Mean ± SD | 1.768 ± 0.035 | 1.560 ± 0.026 | |||
%RSD | 1.991 | 1.695 | |||
PHA | Mobile phase ratio | Buffer 92% | 4.979 | 1.459 | 14.376 |
Buffer 93% | 5.003 | 1.485 | 14.297 | ||
Buffer 94% | 4.971 | 1.450 | 14.498 | ||
Mean ± SD | 4.95 ± 0.068 | 1.46 ± 0.018 | 14.39 ± 0.101 | ||
%RSD | 1.372 | 1.240 | 0.703 | ||
Flow Rate | 1.9 | 4.992 | 1.362 | 14.111 | |
2.0 | 5.003 | 1.352 | 14.498 | ||
2.1 | 4.992 | 1.377 | 14.373 | ||
Mean ± SD | 4.99 ± 0.006 | 1.36 ± 0.012 | 14.32 ± 0.197 | ||
%RSD | 0.127 | 0.922 | 1.378 | ||
pH | 3.8 | 4.992 | 1.369 | 14.461 | |
4.0 | 5.003 | 1.352 | 14.498 | ||
4.2 | 4.981 | 1.399 | 14.278 | ||
Mean ± SD | 4.99 ± 0.011 | 1.37 ± 0.023 | 14.41 ± 0.117 | ||
%RSD | 0.220 | 1.732 | 0.817 |