Table of Contents
ISRN Chromatography
Volume 2012 (2012), Article ID 894965, 8 pages
http://dx.doi.org/10.5402/2012/894965
Research Article

Development and Validation of RP-HPLC Method for the Determination of Ganciclovir in Bulk Drug and in Formulations

Department of Chemistry, University of Mysore, Manasagangotri, Mysore 570006, India

Received 1 April 2012; Accepted 9 May 2012

Academic Editors: E. Boselli, F. M. Lancas, M. P. Marszall, and S. Sarker

Copyright © 2012 P. J. Ramesh 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 simple, rapid, accurate, and precise gradient reversed-phase HPLC (RP-HPLC) method has been developed for the determination of ganciclovir (GNC) in pharmaceuticals. Chromatographic separation was carried out on inertsil ODS C18 (4.6 mm i . d × 2 5 0  mm, 5.0 μm) LC column using ammonium acetate buffer, sodium salt of hexane sulfonic acid as ion-pairing reagent in 1000 mL water, and acetonitrile (90 : 10) (v/v) as mobile phase at a flow rate of 1.0 mL  m i n 1 and with UV detection at 245 nm at column temperature (30°C). The runtime under these chromatographic conditions was 10 min. The method was linear over the range of 0.02–75 μg  m L 1 . The limits of detection (LOD) and quantification (LOQ) values were 4.1 and 20 ng  m L 1 , respectively. The method was successfully extended to study the effect on GNC upon treatment with 2 N NaOH, 2N HCl, and 5% H2O2 for 2 hrs at 80°C and upon exposure to UV (1200 K lux hrs) for 72 hrs and thermal (105°C) for 5 hrs. The proposed method was further applied to the determination of GNC in pharmaceuticals, with good percent recovery. The accuracy and the precision of the method were validated on intraday and interday basis in accordance with ICH guidelines.