Table of Contents
ISRN Chromatography
Volume 2014 (2014), Article ID 689218, 7 pages
http://dx.doi.org/10.1155/2014/689218
Research Article

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Satranidazole from Its Formulation

Dr. L. H. Hiranandani College of Pharmacy, Smt. CHM Campus, Opposite Ulhasnagar Railway Station, Ulhasnagar, Maharashtra 421003, India

Received 27 October 2013; Accepted 1 December 2013; Published 12 January 2014

Academic Editors: A. Sanches Silva and A. Vazquez

Copyright © 2014 Harshal Ashok Pawar and Pooja Rasiklal Joshi. 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

Satranidazole is a new nitroimidazole derivative with potent antiamoebic action and is available in market in the form of tablet and dry syrup either alone or in combination with Ofloxacin. The present study involves the development of simple, accurate, precise, and reproducible reversed phase high performance liquid chromatography (RP-HPLC) method for determination of Satranidazole from its granular dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on BDS Hypersil C18 (250 mm × 4.6 mm, 5 μm) column at 25°C temperature. The mobile phase consists of 0.16% v/v orthophosphoric acid solution, pH 3: acetonitrile in the ratio of 60 : 40 v/v. The UV detection wavelength was 320 nm, and 20 μL sample was injected. The retention time for Satranidazole was about 4.3 minutes. The method was validated for various parameters such as system suitability, precision, recovery, robustness, and ruggedness as per ICH guidelines. The validated RP-HPLC method was found to be specific, linear, precise, and accurate and can be successfully employed for the assay of Satranidazole taste masked granules coated with Eudragit E100 and marketed tablets.