Method development and Validation for Estimation of Irbesartan and Hydrochlorothiazide in Tablet Dosage form by using RPHPLC

Abstract

Abstract In this study Irbesartan (IRN) and Hydrochlorothiazide (HRE) assay was done by utilizing stability indicating RP-HPLC, in which module was carried the water separation 2695, equipped with a detector and chromatographic separation Phenomenex column C18(250×4.mm,5μm) column was operated as stationary phase and mobile phase was combination of phosphate buffer (0.1M, pH 4.1) and methanol in 60% vol and 40% vol, respectively with isocratic elution type. By using 1.0 ml/min flow rate and effluents were observed at 230 nm. The HRE and IRN were eluted at 2.913 and 2.346 min, respectively. Linearity was 75-225 μg/ml (IRN) and 6.25-18.75 μg/ml (HRE). Limit of detection (LOD) and limit of quantification (LOT) for Irbesartan arel.173 For the purposes of μg/ml, and 3,911 μg/ml, 0.409 μg/ml and 1.364 μg/ml for Hydrochlorothiazide. The procedure was developed to suggest consistency by the subjection of medications to stress conditions like acid, alkaline, peroxide, dry heat and sunlight. Both validated criteria were appropriate. The Granry 150H tablet method can be used.