Table 4.
Validation results of artemether and lumefantrine.
Validation Criteria | Artemether | Lumefantrine | |||
---|---|---|---|---|---|
Linearity | Slope | 0.9986 | 1.0342 | ||
Intercept | 0.0028 | 0.0001 | |||
R2 | 0.992 | 0.993 | |||
Trueness | Level | Concentration (mg/mL) | Relative Bias (%) | Concentration (mg/mL) | Relative Bias (%) |
80% | 0.08 | 5.03 | 0.0096 | 5.22 | |
100% | 0.10 | −0.08 | 0.0120 | 1.72 | |
120% | 0.12 | 0.77 | 0.0144 | 0.05 | |
Precision | Level | Repeatability (RSD%)/Intermediate Precision (RSD%) | Repeatability (RSD%)/Intermediate Precision (RSD%) | ||
80% | 2.30/2.40 | 1.75/1.87 | |||
100% | 1.33/2.86 | 2.36/3.36 | |||
120% | 1.18/3.10 | 0.99/0.99 | |||
Accuracy | Level | β-Expectation Tolerance Limits (%) | β-Expectation Tolerance Limits (%) | ||
80% | [0.62, 9.43] | [1.75, 8.69] | |||
100% | [−6.30, 6.15] | [−4.92, 8.37] | |||
120% | [−6.40, 7.93] | [−1.77, 1.87] |