Method Development and Validation of Irbesartan by RP-HPLC

A simple, sensitive, rapid and selective isocratic reversed phase High Performance Liquid Chromatographic (HPLC) method has been developed for Irbesartan from bulk drug using a mobile phase consisting mixture of Menthanol: Water (pH 2.8) (80:20v/v) at the flow rate of 1.0 mL/min. A Cosmosil C18 (250cm x 4.6mm, 5μm) column was used as stationary phase. The retention time of Irbesartan found to be 3.30 min. The eluent were detected at 209nm. Linearity was observed in the concentration range of 60-100ppm for Irbesartan. Percent recoveries obtained for Irbesartan were 98.66%. The correlation coefficient for Irbesartan was found to be 0.997. After performing analysis by different analysts, it was found that the RPHPLC method for the determination of Irbesartan was found to be Rugged. Percent RSD for robustness was well within the acceptable USP limits, ensuring that the proposed method was robust. The LOD were 0.074ug/ml Irbesartan. For Irbesartan, the LOQ were found to be 0.24μg/ml. This demonstrated that the developed RP-HPLC method was simple, linear, precise, accurate, robust, and Rugged, could be conveniently adopted for the routine quality control analysis of Irbesartan.