Validation Parameters Of Rp-Hplc Method For Simultaneous Estimation Of Naproxen Sodium And Esomeprazole Magnesium Trihydrate

Abstract

An isocratic RP-HPLC method was developed and validated for the Simultaneous estimation of Naproxen sodium and Esomeprazole magnesium trihydrate in Pharmaceutical tablet dosage form. The separation was achieved by using a reversed-phase C 18 column(Thermo eletrole, ODS, 250mm × 4.6 mm i.d, 5μm) at ambient temperature with mobile phase consisting of Phosphate buffer (pH adjust to 3.8using OPA): Acetonitrile : Methanol (30:50:20v/v). The flow rate was 1.0 ml/min. Detection was carried out at a wavelength of 220 nm. Retention time of Naproxen sodium and Esomeprazole magnesium trihydrate were found tobe2.417 and 3.903min respectively. The proposed method was validated for selectivity, precision, linearity and accuracy. The assay method was found to be linear from 75-175µg/ml and 3-7µg/ml for Naproxen sodium and Esomeprazole magnesium trihydrate respectively. All validation parameters were within the acceptable range.