Method Development and Its Validation for Simultaneous Estimation of Domperidone and Esomeprazole by RP-HPLC in Combination Tablet Dosage Form

Abstract

A simple and validated reverse phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Esomeprazole and Domperidone. Different HPLC Chromatographic conditions were used to find out the optimum chromatographic condition for best elution of drugs. Good chromatographic separation was achieved on Develosil ODS HG-5 RP C18 (15cmX4.6mm, 5mm Particle size), analytical column using a mixture of Potassium dihydrogen phosphate buffer pH: acetonitrile in the ratio of 45:55 v/v used as mobile phase at the flow rate of 1 ml/min and detector wavelength at 284nm. The validation of the proposed method was carried out for specificity, linearity and range, accuracy, precision, limit of detection and limit of quantification. Linearity range was found to be 0-140 µg/ml and 0-150 µg/ml with correlation coefficients of 0.995 & 0.994 and retention time of 2.59 and 3.85 min for Domperidone and Esomeprazole respectively. The LOD was found to be 0.341 mg/ml and 2.031 mg/ml and LOQ was found to be 1.023 mg/ml and 6.093 mg/ml respectively. The result shows the developed method is yet another suitable method for assay and stability studies which can help in the analysis of Domperidone & Esomeprazole in different formulations.