Development and validation of a HPLC method for separation and simultaneous determination of process-related substances ofIrbesartan in bulk drugs

A simple, inexpensive and rapid reversed-phase high-performance liquid chromatographic method has been developed for the separation and simultaneous determination of related substances of Irbesartan, an anti-hypertensive drug, in bulk drugs. Degradation studies were performed on the bulk drug by heating to 105i‚°C, exposure to UV light at an energy of 200 Watt hours/m2 and to Visible light at an illumination of not less than 1.2 million lux hours, acid (0.5 N Hydrochloric acid), base (0.05 N sodium hydroxide), aqueous hydrolysis and oxidation with 6.0%v/v hydrogen peroxide. Considerable degradation was observed under acid, base and oxidation conditions. Good resolution between the peaks corresponding to impurities produced during synthesis, degradation products and the analyte was achieved on a Symmetry shield RP 18 LC column using a mobile phase consisting of a mixture of aqueous potassium dihydrogen phosphate and acetonitrile. Validation of the method was carried out as per ICH requirements.