Validation criteria

Level

Quinine sulfate

of the tablet

Quinine bichlorhydrate

of the oral drop

Amoxicillin 3H₂O

of the capsule

Metronidazole benzoate of the suspension

Trueness:

Absolute bias (µg/mL)

(Relative bias (%))

1

0.01 (0.26)

−0.11 (−2.77)

0.04 (0.24)

0.01 (−0.15)

2

0.06 (1.58)

−0.05 (−0.87)

0.04 (0.18)

0.11 (1.81)

3

0.02 (0.36)

0.02 (0.29)

0.15 (0.59)

−0.01 (−0.11)

4

0.06 (0.75)

−0.20 (−1.97)

0.20 (0.66)

0.02 (0.15)

5

0.03 (0.33)

−0.11 (0.88)

0.02 (0.06)

−0.01 (−0.33)

Precision:

Repeatability (RSD in %)/ Intermediate precision (RSD in %)

1

1.41/1.41

1.22/1.63

1.23/1.23

1.63/1.63

2

1.11/1.42

2.22/2.22

1.23/1.23

0.79/1.10

3

0.99/1.07

1.09/1.09

1.01/1.01

1.19/1.24

4

0.73/0.73

1.48/1.54

0.68/0.68

0.77/0.79

5

0.53/0.83

2.36/2.62

0.74/1.14

1.29/1.29

Accuracy:

β-expectation tolerance interval (µg/mL)

(Relative β-expectation tolerance interval (%))

1

1.94 - 2.07

(−3.20/3.71)

3.69 - 4.09

(−7.68/−2.14)

14.58 - 15.49

(−2.77/3.24)

3.83 - 4.15

(−4.14/3.84)

2

3.89 - 4.23

(−2.69/5.84)

5.62 - 6.27

(−6.31/4.56)

19.43 - 20.64

(−2.83/3.19)

5.91 - 6.31

(−1.47/5.09)

3

5.86 - 6.18

(−2.34/3.07)

7.81 - 8.24

(−2.38/2.96)

24.53 - 25.77

(−1.87/3.06)

7.74 - 8.24

(−3.20/2.98)

4

7.92 - 8.20

(−1.03/2.53)

9.42 - 10.19

(−5.79/1.86)

29.70 - 30.70

(−1.02/2.33)

9.82 - 10.21

(−1.82/2.11)

5

9.76 - 10.30

(−2.37/3.04)

11.29 - 12.92

(−5.89/7.64)

33.75 - 36.29

(−3.57/3.69)

11.62 - 12.37

(−3.18/3.14)

Uncertainty:

Relative expanded uncertainty (%)

1

2.78

3.60

2.60

3.44

2

3.12

4.68

2.60

2.42

3

2.28

2.30

2.13

2.63

4

1.54

3.26

1.44

1.68

5

1.86

5.63

2.53

2.72

Linearity:

Slope

1.003

1.014

1.003

0996

Intercept

0.017

−0.161

0.020

0.056

R²

0.999

0.996

0.999

0.999