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Rapid LC-MS Compatible Stability Indicating Assay Method for Azilsartan Medoxomil Potassium

Debasish Swain, Gayatri Sahu and Gananadhamu Samanthula

Azilsartan medoxomil potassium is a new generation antihypertensive drug comes under class of angiotensin receptor blockers. The present study focuses on developing a liquid chromatography-mass spectrometry compatible stability indicating assay method for determination of azilsartan medoxomil potassium in bulk drug and formulations. In order to develop stability indicating assay method initially the drug was subjected to stress conditions of hydrolysis (acid, base and neutral), oxidation, photolysis and thermal degradation. Degradation of the drug was observed in acid, alkaline, neutral and peroxide conditions. Separation of drug from the resulting degradation products was achieved on a Symmetry C-18 column (150 mm × 4.6 mm × 5 μm) using 0.02% trifluroacetic acid and acetonitrile as mobile phase with gradient elution. The flow rate was 1.0 mL/min and quantification was carried out using ultraviolet detection at wavelength 254 nm. The method was validated according to ICH Q2 (R1) guideline for selectivity, linearity, accuracy and precision. The drug was well separated from all the degradants and its peak purity was ascertained through photodiode array and mass spectrometric detection. All the degradation products were characterised using ion trap mass spectrometer. The method was found to be linear over the concentration range of 160.00-240.00 μg/mL with correlation coefficient >0.999. The interday and intraday precision values for azilsartan medoxomil potassium was found to be within 2.0% relative standard deviation (Graphical abstract).