| System suitability parameter |
Robustness parameter |
EZE |
SIM |
| Resolution |
No change (repeatability) |
- |
17.22 |
| pH of buffer (+0.2 units) |
- |
17.13 |
| pH of buffer (-0.2 units) |
- |
16.65 |
| Column temperature (+5%) |
- |
17.18 |
| Column temperature (-5%) |
- |
16.97 |
| Flow rate (+5%) |
- |
17.18 |
| Flow rate (-5%) |
- |
17.12 |
| Organic content of mobile phase (+2%) |
- |
17.72 |
| Organic content of mobile phase (-2%) |
- |
16.63 |
| USP Tailing |
No change (repeatability) |
1.51 |
1.11 |
| pH of buffer (+0.2 units) |
1.52 |
1.12 |
| pH of buffer (-0.2 units) |
1.51 |
1.11 |
| Column temperature (+5%) |
1.51 |
1.11 |
| Column temperature (-5%) |
1.52 |
1.13 |
| Flow rate (+5%) |
1.52 |
1.12 |
| Flow rate (-5%) |
1.50 |
1.11 |
| Organic content of mobile phase (+2%) |
1.51 |
1.12 |
| Organic content of mobile phase (-2%) |
1.52 |
1.11 |
| Column effciency |
No change (repeatability) |
28021 |
21342 |
| pH of buffer (+0.2 units) |
28600 |
21898 |
| pH of buffer (-0.2 units) |
28167 |
21274 |
| Column temperature (+5%) |
29802 |
23137 |
| Column temperature (-5%) |
27964 |
20422 |
| Flow rate (+5%) |
28676 |
21570 |
| Flow rate (-5%) |
26779 |
21646 |
| Organic content of mobile phase (+2%) |
26120 |
22622 |
| Organic content of mobile phase (-2%) |
31419 |
20946 |
