6.2.5
BIOANALYTICAL
METHOD
Bioanalytical Method for Bupropion and Its Metabolites in NDA 21-515
A
liquid chromatography [blacked out] mass spectrometry (LC-MS/MS)
assay was used for analysis of bupropion and its metabolites, bupropion
erythroamino alcohol, bupropion threoamino alcohol, and hydroxybupropion in
human plasma.
[blacked out]
Standard
operating procedures (SOPs) were in place for sample preparation, the analytical
procedure, for acceptance of the bioanylytical run (system suitability and
acceptance of calibration standards and quality control (QC) samples), and
acceptance criteria for subject samples, including sample dilution.
Selectivity,
Accuracy, Precision, and Recovery
[blacked out]
88
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