Research Article

Quantification of Lumefantrine in Human Plasma Using LC-MS/MS and Its Application to a Bioequivalence Study

Table 3

Stability results for lumefantrine ( ).

StabilityLevel % CV % CV% Change

Autosampler (34 h, 10°C)LQC633.333.38605.194.77−4.44
HQC15829.361.4015232.731.93−3.77
Bench top (17 h at room temp.)LQC633.333.38600.271.51−5.22
HQC15829.371.4015292.073.51−3.38
Coolant (26 h, −70°C)LQC633.333.38 622.32 3.91 −1.74
HQC15829.371.4015514.031.58−1.99
Reinjection (29 h, 2–8°C)LQC555.864.90575.115.283.46
HQC16044.532.9515570.59 2.52 −2.95
3rd freeze-thaw cycle (−70°C)LQC578.49 6.01 581.93 9.99 −0.59
HQC14834.03 6.68 16427.64 4.79 10.74
Long term (221 days, −70°C)LQC555.86 4.90 578.54 3.67 4.08
HQC16044.532.95 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.