Reverse Phase –Hplc Method Development, Validation And Stability Indicating Studies Of Deferasirox In Its Api And Pharmaceutical Dosage Form

Abstract

From the literature review, we have noticed the use of Acetonitrile, buffer and Ortho phosphoric acid(OPA) as the mobile phases for the analytical work of Deferasirox and the reported retention time was in between 8.7 to 6.4min at the flow rates of greater than 1ml/min. In the present work, we have used Methanol and 0.1% OPA (80:20v/v) as the mobile phase and the retention time was 6.2 minutes at the flow rates of 1.2ml/min.  The Column was C18(4.6mm x 250mm;5µm) and detector was UV-PDA (λmax 247nm).  Linearity concentrations were 10µg/ml to 50µg/ml(R2-0.9952). All the validation parameters and degradation studies complied with the limits of ICH Q2R1 guidelines. This developed method consumes nearly 50% less mobile phase with methanol and water containing OPA(0.1%) which are cheaper and environment friendly. Thus, the method can be advised to do the routine analysis of Deferasirox in its API and formulation.