Table of Contents
Chromatography Research International
Volume 2014 (2014), Article ID 736761, 8 pages
http://dx.doi.org/10.1155/2014/736761
Research Article

Development and Validation of a Novel RP-HPLC Method for Estimation of Losartan Potassium in Dissolution Samples of Immediate and Sustained Release Tablets

1Research Scholar, Ultra College of Pharmacy, 4/235 College Road, Thasildar Nagar, Madurai, Tamil Nadu 625020, India
2Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, 4/235, College Road, Thasildar Nagar, Madurai, Tamil Nadu 625020, India

Received 26 October 2013; Accepted 11 March 2014; Published 9 April 2014

Academic Editor: Irene Panderi

Copyright © 2014 Harshal A. Pawar and K. G. Lalitha. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A simple, rapid, selective, and reproducible reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Losartan potassium in dissolution samples of Losartan potassium immediate and sustained release tablets. Analysis was performed on an Agilent, Zorbax Eclipse XDB C18 column (150 mm × 4.6 mm, 5 μm) with the mobile phase consisting of orthophosphoric acid (0.1% v/v)—acetonitrile (55 : 45, v/v) at a flow rate of 1.0 mL/min. UV detection was performed at 225 nm and the retention time for Losartan was about 2.6 minutes. The calibration curve was linear (correlation coefficient = 0.999) in the selected range of analyte. The optimized dissolution conditions include the USP apparatus 2 at a paddle rotation rate of 50 rpm and 900 mL of pH 6.8 phosphate buffer as dissolution medium, at C. The method was validated for precision, linearity, specificity, accuracy, limit of quantitation, and ruggedness. The system suitability parameters, such as theoretical plate, tailing factor and relative standard deviation (RSD) between five standard replicates, were well within the limits. The stability result shows that the drug is stable in the prescribed dissolution medium.