Determination of Irbesartan in Pharmaceutical Preparations by HPLC

In this study, a high-performance liquid chromatography (HPLC) method was developed to analyze irbesartan in both pure and pharmaceutical formulations. The mobile phase consisted of an acetonitrile-1.0 mM potassium dihydrogen phosphate solution (30:70, v/v), adjusted to pH 3.0 with phosphoric acid. The analysis was performed using an Ace C18 column, and a UV detector was employed to monitor the eluent at 220 nm. With a flow rate of 1.0 mL min-1, the analysis was completed in under 6 minutes. The calibration curve was linear across the concentration range of 0.10-5.0 μg mL-1. The accuracy of the method (relative error) for irbesartan was better than 2.67%, and the intra- and inter-day precision values were below 3.23%. The mean recovery of irbesartan in pharmaceutical formulations was 101.4%. The limits of detection and quantitation were found to be 0.03 and 0.10 μg mL-1, respectively. Furthermore, the method proved to be effective for quantifying the drug and confirming the consistency of the formulation content in commercial irbesartan dosage forms.