Quantification of Lumefantrine in Human Plasma Using LC-MS/MS and Its Application to a Bioequivalence Study
Table 3
Stability results for lumefantrine ().
Stability
Level
% CV
% CV
% Change
Autosampler (34 h, 10°C)
LQC
633.33
3.38
605.19
4.77
−4.44
HQC
15829.36
1.40
15232.73
1.93
−3.77
Bench top (17 h at room temp.)
LQC
633.33
3.38
600.27
1.51
−5.22
HQC
15829.37
1.40
15292.07
3.51
−3.38
Coolant (26 h, −70°C)
LQC
633.33
3.38
622.32
3.91
−1.74
HQC
15829.37
1.40
15514.03
1.58
−1.99
Reinjection (29 h, 2–8°C)
LQC
555.86
4.90
575.11
5.28
3.46
HQC
16044.53
2.95
15570.59
2.52
−2.95
3rd freeze-thaw cycle (−70°C)
LQC
578.49
6.01
581.93
9.99
−0.59
HQC
14834.03
6.68
16427.64
4.79
10.74
Long term (221 days, −70°C)
LQC
555.86
4.90
578.54
3.67
4.08
HQC
16044.53
2.95
17745.02
3.86
10.60
: mean value of comparison samples (original concentrations before storage) concentrations (ng/mL); : mean value of stability samples (measured concentration after storage) concentrations (ng/mL); CV: coefficient of variation; h: hours, temp: temperature.