Table 2.
Trueness and precision
| Total Camptothecin | |||||||
|---|---|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | CV (%) | WRP (%) | BRP (%) | n |
| 10 (T-LLOQ) | 10.34 | 0.87 | 3.43 | 8.44 | 4.54 | 8.01 | 20 |
| 30 (T-LQC) | 33.03 | 1.71 | 10.09 | 5.18 | 3.39 | 4.29 | 19 |
| 3000 (T-MQC) | 3255 | 101 | 8.49 | 3.10 | 2.66 | 1.79 | 20 |
| 9000 (T-HQC) | 9249 | 386 | 2.77 | 4.17 | 3.73 | 2.10 | 20 |
| 30000 (T-DQC) | 32510 | 585 | 8.36 | 1.80 | 1.88 | -* | 20 |
| Free Camptothecin | |||||||
|---|---|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | CV (%) | WRP (%) | BRP (%) | n |
| 1 (F-LLOQ) | 1.06 | 0.06 | 6.20 | 5.98 | 4.64 | 4.24 | 20 |
| 3 (F-LQC) | 3.16 | 0.09 | 5.18 | 2.72 | 2.55 | 0.99 | 20 |
| 300 (F-MQC) | 319.2 | 12.6 | 6.40 | 3.94 | 2.25 | 3.65 | 20 |
| 900 (F-HQC) | 966.5 | 54.1 | 7.39 | 5.59 | 3.86 | 4.56 | 20 |
| 10000 (F-DQC) | 9703 | 404 | 7.81 | 4.17 | 2.65 | 3.62 | 20 |
Abbreviations: GM, grand mean; SD, standard deviation; DEV (%), relative deviation from nominal value; CV (%), coefficient of variation; WRP (%), within-run precision; BRP (%), between-run precision; n, number of replicate observations within each validation run.
*
- No additional variation was observed as a result of performing the assay in different runs.