Development and validation of hplc method for the determination of losartan in human plasma

Abstract

A simple, rapid and sensitive isocratic method for detection and quantification of losartan in plasma has been developed. The assay consisted of reversed HPLC with UV detection. Losartan chromatographed on a CIS column, mobile phase consisting of 50:50, acetonitrile and 0. 1% of glacial acetic acid in water. The mobile phase was pumped at a flow rate of 1. Oml/min and the eluent was monitored at 230nm. Valsartan (20μg/ml) was used as internal standard. Sensitivity of the assay was <50ng/ml. Intra-and inter-assay variations were <2% respectively. Recovery of losartan was 98-99% . Using 500μ1 of plasma sample, standard curves were linear from 0. 05 to 0. 5 μg/ml (r2). 9926). The assay has been successfully applied to measuring plasma concentrations of losartan in patients receiving a daily dose of losartan (12. 5-100mg). The validation data has been studied. This method provides sufficient reproducibility, sensitivity and specificity for clinical pharmacokinetic studies.