Table 2.
Robustness of the method for doxorubicin (DOX)
| (a) Robustness | |||
|---|---|---|---|
| Conditions | LQC (2.90 ng/ml) | MQC(1000 ng/ml) | HQC (2000 ng/ml) |
| Mobile phase [ACN: 0.1% formic acid (50:50: v/v)] | |||
| Negative level (49.9:50.10, n = 3) | 2.70 ± 0.11 (4.07%) | 970.10 ± 11.01 (1.13%) | 1967.89 ± 15.09 (0.77%) |
| Zero level (50:50, n = 3) | 2.84 ± 0.02 (0.70%) | 981.89 ± 13.99 (1.42%) | 1988.99 ± 11.89 (0.60%) |
| Positive level (50.10:49.90, n = 3) | 2.75 ± 0.12 (4.36%) | 974.91 ± 12.08 (1.24%) | 1970.01 ± 14.09 (0.72%) |
| Flow rate (0.20 ml/min) | |||
| Negative level (0.19, n = 3) | 2.61 ± 0.09 (3.45%) | 969.01 ± 11.33 (1.17%) | 1971.61 ± 19.02 (0.96%) |
| Zero level (0.20, n = 3) | 2.79 ± 0.081 (2.90%) | 988.78 ± 12.01 (1.21%) | 1981.01 ± 12.91 (0.65%) |
| Positive level (0.21, n = 3) | 2.70 ± 0.12 (4.44%) | 972.05 ± 10.56 (1.09%) | 1967.29 ± 11.56 (0.59%) |
| pH of mobile phase (default pH = 7.2) | |||
| Negative level (6.9, n = 3) | 2.61 ± 0.061 (2.34%) | 971.98 ± 5.99 (0.62%) | 1968.45 ± 11.05 (0.56%) |
| Zero level (7.2, n = 3) | 2.84 ± 0.012 (0.42%) | 985.11 ± 8.92 (0.91%) | 1985.42 ± 10.66 (0.54%) |
| Positive level (7.4, n = 3) | 2.69 ± 0.058 (2.16%) | 974.91 ± 6.30 (0.65%) | 1977.00 ± 15.99 (0.81%) |
| (b) Ruggedness | ||||
|---|---|---|---|---|
| QC ID | Theoretical content (ng/ml) | Mean concentration observed (ng/ml) | Accuracy a (%) | CV (%) b |
| LOQQC | 1.01 | 0.95 ± 0.021 | 94.60 | 2.21 |
| LQC | 2.90 | 2.81 ± 0.088 | 96.90 | 3.13 |
| MQC | 1000.00 | 981.01 ± 9.33 | 98.10 | 0.95 |
| HQC | 2000.00 | 1979.01 ± 5.00 | 98.95 | 0.25 |
Values (Mean ± SD) are derived from 6 replicates:
a Accuracy (%) = Mean value of [(mean observed concentration)/(theoretical concentration)] × 100
b Precision (%): coefficient of variance (percentage) = standard deviation divided by mean concentration found × 100; Theoretical contents; LOQQC: 1.01 ng/ml, LQC: 2.90 ng/ml; MQC: 1000 ng/ml; and HQC: 2000 ng/ml