Development and Validation of a New Stability-Indicating Liquid Chromatographic Method for the Simultaneous Determination of Eprosartan and Hydrchlorothiazide in Tablets

Abstract

A validated stability-indicating high-performance liquid chromatographic method has been developed for the simultaneous determination of Eprosartan and hydrochlorothiazide in tablet dosage forms. Chromatographic separation was performed on HPLC system of waters Model 2997 using X Bridge Shield RP18 (150 x 3.0 mm i.d., 3.5 µm particle size) column with a mixture of 0.1% formic acid and acetonitrile as mobile phase with a flow rate of 0.8 mL/min (gradient mode) with UV detection at 235 nm. The combinationof drugs was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines.