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Stress Degradation Studies of Irbesartan and Hydrochlorothiazide and Development of Validated Stability Indicating Method

Abstract

Irbesartan and Hydrochlorothiazide were subjected to different ICH prescribed stress conditions like acidic, alkaline, oxidation, reduction, thermal and photo stability condition and found that degraded peaks did not interfere with the peaks of drug under the study. A HPLC system LC Shimadzu UFLC-2000 Prominance LC- 20AD Binary Gradient System. SPDM 20A detector with Rheodyne injector and EnableC18 G column 250x 4.6mm, 5μm. Injection volume of 20μL was injected and eluted with the mobile phase consists of a mixture of 50mM Ammonium acetate: Acetonitrile (70:30% v/v) effluent was monitored at 235 nm using PDA detector. The method was linear over the concentration range of 150-350μg/ml (r2 = 0.999) with a limit of detection and quantitation of 0.019 and 0.053μg /ml for Irbesartan, and range of 15-35μg/ml (r2 = 0.999) with a limit of detection and quantitation of 0.023 and 0.070μg/ml for Hydrochlorothiazide The method was validated for linearity, range, precision, accuracy, specificity, selectivity and intermediate precision.

Moin Shakeb, SB Puranik and Swamy Sreenivasa

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