Validation of Esomeprazole Magnesium Tri-hydrate in Pharmaceutical dosage form by RP-HPLC Method

摘要

A sensitive and robust novel reverse phase liquid chromatographic method was developed for assay of esomeprazole magnesium trihydrate in its dosage form.For chromatographic study BDS Hypersil C18(150mm x 4.6mm,5 μm)was used in on isocratic system at ambient temperature.The selected mobile phase made up of buffer and acetonitrile in proportion 75:25 %(v/v).The flow rate of 1 ml/min.was used in study.The effluent study was done at wavelength 280 nm.The retention time was observed at 3.8 min.The linearity was observed in concentration range as 20 to 60 μg/ml.The correlation coefficient is less than 1.The ICH guidelines were used for system suitability,linearity,accuracy and precision studies.The accuracy and precision were found to be well within the acceptable limit.The method was successfully applied for assay of Esomeprazole magnesium trihydrate in tablets with good recoveries.