Development and validation of reverse phase HPLC method for determination of ortho and meta isomers in N-methyl fluoxetine oxalate

The present work deals with the development and validation of a stability indicating reverse phase HPLC method for the determination of ortho and meta isomers in N-Methyl fluoxetine oxalate on Zorbax Eclipse XDB C-18 column (150 mm × 4.6 mm,5 μm). A mobile phase consisting of solution-A (0.05M Disodium hydrogen ortho phosphate with Triethylamine and the resulting mixture pH adjusted to 3.0) and solution-B [Methanol: Tetrahydrofuran /80:20 (v/v)] in the ratio of 60:40 (v/v). The flow rate was 1.5 ml/min. The separation was performed at 40 °C and detection was carried out at λ215 nm. The developed method was statistically validated for the linearity,accuracy,specificity,robustness,LOD and LOQ. The specificity of the method was ascertained by forced degradation studies with acid,alkali,oxidation,thermal and photolysis. The degraded products were well separated from the main peak with significant differences in their retention time. © 2012 Moment Publication.