Simultaneous Determination of Eprosartan Mesylate and Hydrochlorthiazide in Pharmaceutical Dosage form by Reverse Phase High Performance Liquid Chromatography

Devika G S,M Sudhakar,J Venkateshwara Rao

doi:10.4172/2153-2435.1000122

Abstract

A simple, rapid, sensitive and accurate reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous determination of Eprosartan mesylate and hydrochlorthiazide in combination.Chromatographic separation of the two drugs was performed on a Purospher BDS C18 column (150 mm× 4.6 mm id, 5μm particle size). The mobile phase comprising of acetonitrile: methanol: 0.01M KH 2 PO 4 buffer (40:40:10) was delivered at a flow rate of 1.0mL/min. The pH of the mobile phase is adjusted to 4 with ortho phosphoric acid .Detection was performed at 270nm.The total run time is 5 min and the retention time of Eprosartan mesylate is 3.56 min and hydrochlorthiazide is 4.62 min respectively.The described method is linear for the assay of Eprosartan mesylate and hydrochlorthiazide over a concentration range of 216-576μ g/mL and 9-24μg/mL respectively. Results of the analysis have been validated and by recovery studies.The excipients present in the formulations do not interfere with the assay procedure.The developed method was successfully applied to determine Eprosartan mesylate and hydrochlorthiazide in pharamaceutical formulations.

Highlights

The absolute risk of cardiovascular events is mainly determined by high blood pressure, there are some other important contributors, such as age, race and presence of other cardio vascular risk factors
Most hypertensive patients require more than one agent in order to achieve adequate blood pressure (BP) control [3]
Eprosartan mesylate[EPR] is chemically monomethanesulfonate of (E)-2-butyl-1-(pcarboxybenzyl)-α-2-thienylmethylimidazole-5-acrylicacid (Figure 1) is a new antihypertensive agent as an angiotension II receptor antagonist that is highly selective to elict a higher reduction in systolic blood pressure than other anti hypertensilve drugs [4,5]

Summary

Introduction

The absolute risk of cardiovascular events is mainly determined by high blood pressure, there are some other important contributors, such as age, race and presence of other cardio vascular risk factors. Anti hypertensive therapy enables to reduce considerably the risk of developing cardiovascular complications that cause a high mortality rate in the industrialized countries [1,2]. Eprosartan mesylate[EPR] is chemically monomethanesulfonate of (E)-2-butyl-1-(pcarboxybenzyl)-α-2-thienylmethylimidazole-5-acrylicacid (Figure 1) is a new antihypertensive agent as an angiotension II receptor antagonist that is highly selective to elict a higher reduction in systolic blood pressure than other anti hypertensilve drugs [4,5]. New tablet formulation in combination of Eprosartan mesylate 600mg and Hydrochlorthiazide 25 mg is commercially available in market (Teventen® HCT) for the treatment of edema and hypertension. No refernces were found for simultaneous determination of Eprosartan mesylate and Hydrochlorthiazide in pharmaceutical preparation by using RP-HPLC.In this work we introduce an simple, fast, isocratic RP-HPLC method for simultaneous determination of this combination in tablet formulation.The proposed method was developed, optimized, and validated according to International conference on Hormonization (ICH) guidelines [25]

Materials and Methods

Method validation

Findings

Conclusion