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Table 3 Stability of larotrectinib in mice and human plasma (n = 5)

From: Development and validation of an LC-MS/MS method for monitoring larotrectinib, a tropomyosin-related kinase inhibitor, in mouse and human plasma and application to pharmacokinetic studies

Condition tested

LQC (15 ng/mL)

MQC (500 ng/mL)

HQC (8000 ng/mL)

 

Mean (ng/mL)

RSDa (%)

REb (%)

Mean (ng/mL)

RSDa (%)

REb (%)

Mean (ng/mL)

RSDa (%)

REb (%)

Mice

 Control samples (freshly prepared)

0.66

1.78

1,73

 Freeze-thaw (− 80 °C, 3 cycles)

15.45

2.68

3.01

466.17

2.82

− 6.77

8205.57

2.08

2.57

 Bench (RT, 24 h)

14.76

3.70

− 1.62

507.26

3.53

1.45

8456.82

0.58

5.71

 Refrigerator (4 °C, 24 h)

16.02

2.75

6.77

502.51

2.75

0.50

8368.14

0.43

4.60

 Freezer (− 20 °C, 24 h)

14.56

0.55

− 2.94

486.76

1.29

− 2.65

8195.62

2.09

2.45

 Freezer (− 80 °C, 4 weeks)

15.08

1.69

0.54

469.95

2.63

− 6.01

7988.80

0.32

− 0.14

 Post-preparative (RT, 24 h)

14.74

0.86

− 1.76

504.12

4.51

0.82

8319.10

1.62

3.99

 Post-preparative (4 °C, 24 h)

15.35

0.32

2.36

466.07

2.43

− 6.79

7845.21

1.35

− 1.93

 Post-preparative (4 °C, 1 week)

14.54

0.76

− 3.04

484.56

1.11

− 3.09

7868.35

0.58

− 1.65

Human

 Control samples (freshly prepared)

9.51

4.15

0.22

 Freeze-thaw (− 80 °C, 3 cycles)

15.30

1.53

1.98

528.25

0.40

5.65

8264.74

0.65

3.31

 Bench (RT, 24 h)

14.24

2.39

− 5.08

481.51

0.95

− 3.70

8377.79

0.82

4.72

 Refrigerator (4 °C, 24 h)

15.20

0.14

1.37

483.95

3.23

− 3.21

8368.67

1.98

4.61

 Freezer (− 20 °C, 24 h)

15.23

1.54

1.55

531.76

1.03

6.35

7999.97

0.87

0.00

 Freezer (− 80 °C, 4 weeks)

14.82

2.07

− 1.17

540.29

1.39

8.06

8002.13

5.89

0.03

 Post-preparative (RT, 24 h)

14.85

1.49

− 1.02

550.94

3.75

10.19

8335.96

1.60

4.20

 Post-preparative (4 °C, 24 h)

14.85

3.49

− 1.01

488.57

1.68

− 2.29

8307.94

1.05

3.85

 Post-preparative (4 °C, 1 week)

15.37

1.68

2.50

470.24

2.17

− 5.95

8167.04

0.99

2.09

  1. astandard deviation of concentration/mean concentration × 100%
  2. b(calculated concentration − theoretical concentration)/theoretical concentration × 100%