Table 2.
Evaluation of intraday precision and accuracy for bisoprolol spiked quality control samples.
| Cth = 3 ng/mL | Cth = 25 ng/mL | Cth = 75 ng/mL | ||||
|---|---|---|---|---|---|---|
| Cexp (ng/mL) | % nominal | Cexp (ng/mL) | % nominal | Cexp (ng/mL) | % nominal | |
| (1) | 2.912 | 98.391 | 22.524 | 91.263 | 69.203 | 93.468 |
| (2) | 3.003 | 101.439 | 24.862 | 100.737 | 68.525 | 92.552 |
| (3) | 3.262 | 110.192 | 23.762 | 96.281 | 66.781 | 90.196 |
| (4) | 2.829 | 95.568 | 25.189 | 102.062 | 76.691 | 103.580 |
| (5) | 3.018 | 101.960 | 21.739 | 88.085 | 65.844 | 88.931 |
| (6) | 2.854 | 96.431 | 21.371 | 86.593 | 74.009 | 99.958 |
| Mean | 2.980 | 100.664 | 23.241 | 94.170 | 70.176 | 94.781 |
| SD | 0.158 | 1.610 | 4.268 | |||
| CV % | 5.296 | 6.927 | 6.082 | |||
| Acceptance criteria | ||||||
| 67% Total QCs must be 100 ± 15% nominal values | ||||||
| 50% QCs per level must be 100 ± 15% nominal values | ||||||
| Mean % nominal 100 ± 15% | ||||||
| CV (%) ≤ 15% | ||||||
Cth = theoretical concentration. Cexp = experimental concentration. SD = standard deviation. CV % = coefficient of variation