Table 9 Robustness studies (variation of flow) for standard and test solutions of sofosbuvir
Peak area (AU) | Retention time (min) | |||
|---|---|---|---|---|
Standard | Test | Standard | Test | |
Increased flow rate (1.1 ml/min) | ||||
1 | 5508834 | 5678165 | 3.346 | 3.340 |
2 | 5517126 | 5693588 | 3.344 | 3.338 |
3 | 5517268 | 5671572 | 3.342 | 3.339 |
Mean | 5514409 | 5681108 | 3.344 | 3.339 |
Std. deviation | 4829 | 11299 | 0.002 | 0.001 |
% RSD | 0.088 | 0.199 | 0.060 | 0.022 |
% Assay | 99.90% | |||
Decreased flow rate (0.9 ml/min) | ||||
1 | 6800653 | 6652974 | 4.076 | 4.081 |
2 | 6809922 | 6648743 | 4.078 | 4084 |
3 | 6802508 | 6658755 | 4.081 | 4.085 |
Mean | 6804361 | 6653490 | 4.078 | 4.083 |
Std. deviation | 4904 | 5025.96 | 0.002 | 0.002 |
% RSD | 0.072 | 0.076 | 0.058 | 0.052 |
% Assay | 99.91% | |||