TABLE 3.
METHOD VALIDATION RESULTS FOR FOUR PRESERVATIVES
Validation steps | Parameters | Results |
Acceptance | |||
---|---|---|---|---|---|---|
PhOE | MP | EP | PP | criteria | ||
Repeatability | RSD (%, n = 6) | 0.307 | 0.097 | 0.317 | 0.283 | X < 2 |
Int. precision | ||||||
Day 1 | RSD (%) | 0.329 | 0.130 | 0.365 | 0.401 | X < 2 |
Day 2 | RSD (%) | 0.242 | 0.165 | 0.417 | 0.372 | X < 2 |
Standard stability (48 h data) | Change in response factor (%) | 0.13 | 0.13 | 0.13 | 0.15 | X < 2 |
System suitability | RSD (%, n = 6) | 0.11 | 0.15 | 0.09 | 0.26 | X < 2 |
RSD: Relative standard deviation.