Stability indicating RP-HPLC method for determination of azilsartan medoxomil in bulk and its dosage form

Abstract

A simple, accurate, rapid, precise and novel Reverse phase High Pressure liquid chromatographic method (RP-HPLC)
has been developed and validated for determination of Azilsartan Medoxomil in bulk and its dosage form. The selected
and optimized mobile phase was 0.05M potassium dihydrogen phosphate pH 4.0: Acetonitrile in ratio of 60:40 and
conditions were flow rate (1.0 ml/minute), wavelength (248 nm), Run time was 10 min. The retention time was found to
be 3.8.Linearity and range was found to be 10-60 µg/ml. The proposed chromatographic conditions were found
appropriate for the quantitative determination of the drugs. The method was validated for accuracy, precision,
specificity, linearity, robustness, sensitivity, LOD and LOQ.it was also determined by UV-spectroscopy method. The
proposed methods were successfully used for quantitative analysis of tablets. No interference from any component of
pharmaceutical dosage form was observed. Validation studies revealed that methods were specific, rapid, reliable, and
reproducible.