Development and Validation of a Reverse Phase High Performance Liquid Chromatography for Simultaneous Determination of Eprosartan Mesylate and Hydrochlorthiazide in Pharmaceutical Dosage Form

Abstract

The goal of this study was to develop a single isocratic phase HPLC method for the simultaneous determination of Eprosartan mesylate and hydrochlorthiazide . The simultaneous detection of hydrochlorthiazide and eprosartan mesylate in combination has been accomplished through the development and validation of a simple, fast, sensitive, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method. The two medications were separated by chromatography using a Purospher BDS C18 column (250 mm × 4.6 mm id, 5\(\mu\)m particle size). The mobile phase comprising of acetonitrile :methanol:0.01M KH₂PO₄ buffer (40:40:10) was delivered at a flow rate of 1.0mL/min. The detection was carried out at 270nm. The overall run time is 5 minutes, and the retention times for Eprosartan mesylate are 3.56 minutes and 4.62 minutes, respectively. The assay for hydrochlorthiazide and eprosartan mesylate is linear within the concentration range of 216-576\(\mu\) g/mL and 9-24\(\mu\)g/mL respectively. The findings of the analysis have been corroborated by recovery studies. The excipients in the formulations have no effect on the assay method. The suggested approach was used to successfully detect Eprosartan mesylate and hydrochlorthiazide in pharmaceutical formulations.