Validation Criteria

Level

Artemether-Lumefantrine

Artesunate-Amodiaquine

Artemether

Lumefantrine

Artesunate

Amodiaquine

Trueness:

Absolute bias (µg/mL)

(Relative bias (%))

1

1.76 (2.20)

−9.83 (−2.05)

1.40 (1.74)

0.79 (0.33)

2

0.83 (0.69)

−42.54 (−5.91)

−0.97 (−0.81)

0.33 (0.08)

3

−4.34 (−2.71)

36.58 (3.81)

−0.04 (−0.03)

3.78 (0.79)

4

−4.34 (−2.17)

25.12 (2.09)

−4.76 (−2.38)

−2.71 (−0.45)

5

3.22 (1.34)

−44.56 (−3.18)

1.77 (0.74)

8.21 (−0.33)

Precision:

Repeatability (RSD in %)/

Intermediate precision

(RSD in %)

1

3.28/3.28

0.56/0.77

3.29/3.29

3.24/3.24

2

2.04/2.37

0.44/0.67

0.80/0.80

1.28/1.28

3

2.18/2.18

2.11/2.11

0.53/0.53

1.01/1.01

4

1.24/1.24

1.81/1.81

1.19/1.24

1.08/1.08

5

1.63/1.89

0.97/0.99

1.03/1.41

1.13/1.33

Accuracy:

β-expectation tolerance interval (in µg/mL)

(Relative β-expectation tolerance interval (in %))

1

75.33 - 88.19

(−5.83/10.24)

459.30 - 481.10

(−4.32/0.22)

74.96 - 87.85

(−6.31/9.81)

221.80 - 259.80

(−7.60/8.26)

2

113.30 - 128.40

(−5.60/6.97)

662.20 - 692.70

(−8.02/−3.80)

116.70 - 121.40

(−2.76/1.14)

349.10 - 371.50

(−3.04/3.21)

3

147.10 - 164.2

(−8.05/2.63)

947.00 - 1046.00

(−1.35/8.97)

157.90 - 162.00

(−1.32/1.27)

471.90 - 495.60

(−1.68/3.26)

4

189.60 - 201.70

(−5.20/0.86)

1172.00 - 1278.00

(−2.32/6.51)

189.00 - 201.40

(−5.48/0.72)

581.40 - 613.10

(−3.09/2.19)

5

231.2 - 255.2

(−3.67/6.35)

1321.00 - 1390.00

(−5.64/−0.73)

231.00 - 251.30

(−3.42/4.90)

708.30 - 748.20

(−1.63/3.91)

Uncertainty:

Relative expanded uncertainty (%)

1

6.92

1.69

6.94

6.83

2

5.12

1.49

1.68

2.69

3

4.60

4.45

1.12

2.13

4

2.61

3.81

2.64

2.28

5

4.09

2.10

3.10

2.39

Linearity:

Slope

0.994

1.002

0.992

1.010

Intercept

0.329

−8.938

0.703

−2.659

R²

0.994

0.988

0.997

0.998