Table 3.
Validation parameters of formulations F1–F5.
| F1 | F2 | F3 | F4 | F5 | Criterion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SOT | SORB | SOT | SORB | SOT | SORB | SOT | SORB | SOT | SORB | ||
| Repeatability t R (% R.S.D.)a | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | X < 1% |
| Repeatability area (% R.S.D.)a | 0.22 | 0.57 | 0.22 | 0.57 | 0.22 | 0.57 | 0.22 | 0.57 | 0.22 | 0.57 | X < 1% |
| Theoretical plates per meter | 11,810 | 282,650 | 11,810 | 282,650 | 11,810 | 282,650 | 11,810 | 282,650 | 11,810 | 282,650 | — |
| Resolutiona | — | 18.39 | — | 18.39 | — | 18.39 | — | 18.39 | — | 18.39 | R ij > 1.5 |
| Tailing factora | 1.10 | 1.23 | 1.10 | 1.23 | 1.10 | 1.23 | 1.10 | 1.23 | 1.10 | 1.23 | T = 0.8–1.5 |
| Precision (% R.S.D.)b | 0.43 | — | 0.16 | — | 0.49 | 0.98 | 0.26 | 1.51 | 0.21 | 1.11 | X < 5% |
| Linearity (correlation coefficient)c | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | 0.9995 | R > 0.9990 |
| Accuracy recovery (%)b | 101.09 | — | 99.57 | — | 99.59 | 98.26 | 99.93 | 98.70 | 99.35 | 98.57 | X = 100 ± 5% |
| Accuracy (% R.S.D.)b | 0.58 | — | 0.85 | — | 1.44 | 2.27 | 0.71 | 2.07 | 0.57 | 1.14 | X < 5% |
| Selectivity | No interference | No interference | No interference | No interference | No interference | No interference | |||||
aSix injections.
bSix samples, three injections of each sample.
cAt 50, 75, 100, 134, 166, and 200% concentration levels.
SOT: sotalol hydrochloride.
SORB: potassium sorbate.
Fx: formulations with various excipients.
% R.S.D.: relative standard deviation in %.