Table of Contents
Chromatography Research International
Volume 2013, Article ID 432753, 5 pages
http://dx.doi.org/10.1155/2013/432753
Research Article

A Stability Indicating UPLC Method for the Determination of Levofloxacin Hemihydrate in Pharmaceutical Dosage Form: Application to Pharmaceutical Analysis

1Department of Chemistry, Saurashtra University, Rajkot-360 005, Gujarat, India
2Arts Commerce and Science College, Borsad 388540, Gujarat, India

Received 28 February 2013; Accepted 3 June 2013

Academic Editor: Antonio Martín-Esteban

Copyright © 2013 Batuk Dabhi et al. 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 reliable and sensitive isocratic stability indicating RP-UPLC method has been developed and validated for quantitative analysis and content uniformity study of levofloxacin hemihydrate in tablets. An isocratic method for analysis of levofloxacin hemihydrate was archived on ACQUITY UPLC BEH C18 (100*2.1) mm particle size 1.7  columns within shorter runtime of 4 min with a flow rate of 0.400 mL/min and using a photodiode array detector to monitor the eluate at 294 nm. The mobile phase consisted of acetonitrile-buffer (23 : 77 v/v), (buffer: 20 mM K2HPO4 + 1 mL triethylamine in 1 L water, by orthophosphoric acid). Response was a liner function of drug concentration in the range of 0.5–80  g/mL ( ) with a limit of detection and quantification of 0.1 and 0.5  g/mL, respectively. Accuracy (recovery) was between 99.77% and 101.55%. The drug was subjected to oxidation, hydrolysis, photolysis, and thermal degradation. Degradation products resulting from the stress studies did not interfere with the detection of levofloxacin hemihydrate, and the assay is stability indicating.