NOVEL RP-HPLC METHOD FOR THE DETERMINATION OF VILOXAZINE: DEVELOPMENT, VALIDATION, AND APPLICATION TO STABILITY STUDIES

Abstract

Background: Viloxazine hydrochloride is a non-stimulant norepinephrine reuptake inhibitor used for the treatment of attention deficit hyperactivity disorder (ADHD). Materials and Methods: From the literature review, we have noticed the use of Methanol, Acetonitrile, Potassium phosphate, Isopropyl alcohol and Ortho phosphoric acid (OPA), HPLC water, as the mobile phases for the analysis work of Viloxazine Hydrochloride and the reported retention time was in between 2.2 to 3.8 min at the flow rates of greater than 1ml/min. Results and Discussion: In the present work, we have used Methanol and 0.1% OPA (75:25v/v) as the mobile phase and the retention time was 3.1 minutes at the flow rates of 1ml/min. The Column was C18(4.6mm x 250mm;5µm) and detector was UV-PDA (λmax 230nm). Linearity concentrations were 10µg/ml to 50µg/ml(R2-0.9985). All the validation parameters and degradation studies complied with the limits of ICH Q2R1 guidelines. Conclusion: This developed method consumes mobile phase with methanol and water containing OPA (0.1%) which are cheaper and environment friendly. Thus, the method can be considered as green method as compared to the already reported methods.