Abstract
This study describes the development and validation of a 96-microwell-based spectrophotometric assay with high-throughput for the pharmaceutical quality control of fluoxetine (FLX), the selective serotonin reuptake inhibitor antidepressant drug. The assay involved the reaction between FLX and 1,2-naphthoquinone-4-sulphonate (NQS) in alkaline medium (pH 9) producing a red-colored product exhibiting maximum absorption peak (lambda(max)) at 490 nm. The assay reaction was carried out in 96-microwell assay plate and the absorbance of the colored-product was measured by microwell plate absorbance reader. The optimized reaction conditions were established; under which, Beer's law was obeyed in the range of 10-100 mu g/well with good correlation coefficient (0.9988). The limits of detection and quantification were 5.2 and 15.7 mu g/well, respectively. The assay showed high precision as the values of relative standard deviations (RSD) did not exceed 2.83%. The proposed assay was applied successfully for the determination of FLX in its pharmaceutical dosage forms (capsules) with good accuracy and precisions; the label claim percentage was 99.8 +/- 1.2%. The results were compared favorably with those of a reference method. The results demonstrated that the proposed assay has great practical value in routine application for the determination of FLX in pharmaceutical quality control laboratories with high-throughput.