Validation results of pharmaceutical formulation F1 and F2
| F1 | F2 | Criterion | |||
| FUR | MP | FUR | MP | ||
| Repeatability tR (%R.SD)* | 0.26 | 0.12 | 0.26 | 0.12 | X<1% |
| Repeatability area (%R.SD)* | 0.16 | 0.32 | 0.16 | 0.32 | X<1% |
| Number of theoretical plates | 2 499 | 7 892 | 2 499 | 7 892 | - |
| Resolution* | 1.57 | 12.49 | 1.57 | 12.49 | Rij>1.5 |
| Tailing factor* | 1.18 | 1.09 | 1.18 | 1.09 | T=0.8–1.5 |
| Precision (%R.SD)† | 3.55 | 3.54 | 2.13 | 1.52 | X<5% |
| Linearity (correlation coefficient)‡ | 0.9990 | 1.0000 | 0.9990 | 1.0000 | R≥0.9990 |
| Accuracy recovery (%)† | 103.48 | 104.35 | 100.83 | 102.56 | X=100% ± 5% |
| Accuracy (%R.SD)† | 0.61 | 0.36 | 1.75 | 1.84 | X<5% |
| Selectivity | No interference | No interference | No interference | ||
*The results are the arithmetic means of six injections.
†Six samples, three injections of each sample.
‡At 40, 50, 80, 100, 120 and 150% concentration levels.
FUR, furosemide; FUR X, formulations with various excipients; MP, methylparaben; %R.SD, relative SD in %.