Abstract

Priyanka Mondal* and H. P. Singh

ABSTRACT

Adults with major depressive disorder (MDD) are treated with the antidepressant vortioxetine. The mechanism of action (MOA) of vortioxetine is believed to be associated with the suppression of serotonin (5-HT) reuptake. It also possesses other properties, such as agonism of the 5-HT1A and 5-HT3 receptors, but it is uncertain if these have an antidepressant effect. There is no analytical work has been available regarding for estimation of Vortioxetine hydrobromide in Pharmacopoeia. The developed HPLC method for estimation of Vortioxetine hydrobromide makes use of a stationary phase of BDS (150mm x 4.6mm x 5μm), with a mobile phase composition of Acetonitrile: KH2PO4 (60:40). The flow rate was set at 1.0ml/min, and the detection wavelength was 260 nm. Column temperature was maintained at 30°C, with the mobile phase also serving as the diluent. These conditions were determined to be the optimized method. System suitability was assessed through six standard injections, with all results falling comfortably within the acceptance criteria. A linearity study conducted across the range of 25% to 150% levels yielded an R^2 value of 0.999. Precision metrics indicated a repeatability of 0.2 and intermediate precision of 0.6. The limits of detection (LOD) and quantification (LOQ) were established at 0.02μg/ml and 0.06μg/ml, respectively. Utilizing this method, the assay of a marketed formulation showed a 99.90% presence of the active ingredient. Recovery studies were carried out for both the developed method by addition of known amount of standard drug solution of Vortioxetine hydrobromide to pre-analyzed sample solution at three different concentration levels. The suggested techniques were used to analyze the final answers. The recovery studies were satisfactory which shows no interference from the excipients. Thus these developed methods can be used for the routine analysis of Vortioxetine hydrobromide from its dosage form.