DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF IRBESARTAN AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORMS.

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Irbesartan and Hydrochlorothiazide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Phosphate Buffer pH 3.5 (65:35) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 270 nm. The retention time of the Irbesartan and Hydrochlorothiazide was 2.456, 4.312±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Irbesartanand 2.5-12.5mg/ml of Hydrochlorothiazide. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Irbesartan, Hydrochlorothiazide, RP-HPLC, validation.