Development of an HPLC Method for the Estimation of Rebeprazole in Bulk and its Pharmaceutical Formulations

Abstract

A simple, fast and sensitive reverse phase high performance liquid chromatographic method (RP-HPLC) has been developed for the estimation of rabeprazole in bulk and its pharmaceutical formulations. Separation of rabeprazole and tinidazole (internal standard) was achieved on a Hypersil BDS C-18 (250 × 4.6 mm, packed with 5 micron) reversed-phase column, using UV detection at 284 nm. The mobile phase consisted of methanol : water (60 : 40 v/v). The analysis was performed in less than 6 min, with a flow rate of 1.0 mL/min. The calibration curve was linear in the range of 0.1 to 50 μg/mL. The intra and inter-day variation was found to be less than 1% showing high precision of the assay method. The mean recovery of the drug for the solutions containing 2, 6, 10 μg/mL was 99.97 ± 0.78% indicating high accuracy of the proposed HPLC method. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining rabeprazole in bulk drug samples or in capsules.