FLUOXETINE BIOEQUIVALENCE STUDY: QUANTIFICATION OF FLUOXETINE BY LIQUID CHROMATOGRAPHY COUPLED TO MASS SPECTROMETRY
A liquid chromatography method was developed and validated for the determination of fluoxetine in human plasma using paroxetine as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a C 18 analytical column, with water:acetonitrile as mobile phase, run at a flow rate of 0.20 mL/min. The method was linear in the range of 0.2-50 ng/mL and demonstrated acceptable results for the precision, accuracy and stability studies. The method was successfully applied for the bioequivalence study of two tablet formulations of fluoxetine 20 mg after single oral dose administration to healthy human volunteers.