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

摘要

A simple and sensitive reversed-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-l 8(250 x 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 Hg/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 from the solutions containing 2,6,10 mug/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.