ABSTRACT

The present study was aimed to develop a novel, simple, rapid, accurate, stability-indicating ReversedPhase High-Performance Liquid Chromatography method and its validation for the simultaneous estimation of vortioxetin and aripiprazole in synthetic mixture. RP-HPLC method was carried out by isocratic technique on a reversed phase Cosmosil C 18 (250 mm × 4.6 mm, 5 µm) column with acetonitrile: triethanolamine buffer (50:50 V/V, adjusted at pH 3.0) as mobile phase at a flow of 1.0 mL min-1. The detection wavelength was 228 nm. The retention times for vortioxetine and aripiprazole were found to be 5.75 and 4.02 minutes respectively. The calibration curves were linear (r2 ˃0.997) over the concentration range 2-20 µg mL-1 for vortioxetine and 2-32 µg mL-1 for aripiprazole. The values of Relative Standard Deviation (RSD) and percentage recovery were found to be satisfactory. The method was tested and validated as per ICH guidelines. Further, both the methods were compared statistically using student t-test and no significant difference found at 99 % level.