Method Development and Validation of Irbesartan by RP-HPLC Method

Abstract

This study includes development of RP-HPLC method for estimation of Irbesartan. The developed method was validated as per ICH guidelines in terms of specificity, accuracy, linearity, LOD, LOQ, ruggedness and robustness. The assay experiment showed that the contents of Irbesartan estimated in the tablet dosage were free from interference of excipients, which indicate that developed method was specific. Recovery of standard added drugs was found to be 97.2–99.9% for Irbesartan indicating that the proposed method was accurate. After performing analysis by different analyst; it was found that the RP-HPLC method for the determination of Irbesartan % RSD of ruggedness for standard 0.0425% and tablet 0.0142% was found to be rugged. % RSD of robustness was well within the limits for standard 0.36% and tablet 1.87% that the proposed method was robust. The LOD was 0.074 μg/ml for standard drug of Irbesartan. For standard drug of Irbesartan the LOQ were found to be 0.24 μg/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 from it's pharmaceutical dosage form and bulk drug.