Table 11 Robustness studies (variation of flow) for standard and test solutions of phosphoryl impurity
Peak area | Retention time (min) | |||
|---|---|---|---|---|
Standard | Test | Standard | Test | |
Increased flow rate (1.1 ml/min) | ||||
1 | 31293 | 32276 | 5.249 | 5.209 |
2 | 31460 | 33894 | 5.234 | 5.198 |
3 | 31629 | 33877 | 5.221 | 5.200 |
Mean | 31461 | 33349 | 5.235 | 5.203 |
Std. deviation | 168.00 | 929 | 0.014 | 0.006 |
% RSD | 0.534 | 2.787 | 0.273 | 0.111 |
% Assay | 99.65 | |||
Decreased flow rate (0.9 ml/min) | ||||
1 | 36149 | 37515 | 6.313 | 6.364 |
2 | 36950 | 37386 | 6.331 | 6.375 |
3 | 37261 | 37369 | 6.351 | 6.384 |
Mean | 36787 | 37423 | 6.332 | 6.374 |
Std. deviation | 573.71 | 79.84 | 0.019 | 0.010 |
% RSD | 1.560 | 0.213 | 0.303 | 0.157 |
% Assay | 99.69 | |||