Development and validation of HPTLC stability indicating method for estimation of Azilsartan Medoxomil using Fluorescence mode

Abstract

Azilsartan medoxomil is an angiotensin II receptor antagonist used in the management of hypertension. A simple, selective,  and  sensitive  High  Performance  Thin  layer  Liquid  Chromatographic  (HPTLC)  method  for  the determination of Azilsartan medoxomil using fluorescence mode has been developed. The HPTLC separation was achieved on the aluminum backed layer of silica gel 60F254  using Toluene: Methanol (8:2 v/v) as mobile phase. Quantification was achieved using fluorescence mode at 312 nm over the concentration range of 200 to 1000 ng/band with correlation coefficient of 0.991.The recovery study results ranged from 99.33- 99.59%for Azilsartan medoxomil. Retention factor (Rf) was found to be 0.38 ± 0.04respectively. The method is simple and was successfully validated according  to  ICH  guidelines  Q2  (R1).  The  method  showed  acceptable  values  for  assay,  accuracy,  p recision, robustness, sensitivity and stability.