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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IRBESARTAN AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

M.Siddardha*, K.Mangamma And G.Manikumar

ABSTRACT

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Irbesartan and Hydrochlorothiazide in tablet dosage form by using Hypersil BDS C18, 250mm X 4.6 mm, 5μm column. The samples were analyzed by using Methanol: water (80: 20) v/v as a mobile phase at the flow rate of 1.0 ml/min in isocratic mode and detection wavelength is 257 nm. Both the drugs were eluted within 5 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Irbesartan and Hydrochlorothiazide was found to be 2.872 and 3.943 min respectively. The validation was carried according to ICH guidelines. Calibration curve was linear with correlation coefficient of 0.997 and 0.999 over a concentration range of 60μg/mL-240μg/mL and 5-20μg/ml for Irbesartan and Hydrochlorothiazide respectively. The percent recovery was 99.80 for Irbesartan and 99.80 for Hydrochlorothiazide indicating accuracy and reliability of method. So the method can be used for estimation of combination of these drugs in tablet dosage form.

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