Table of Contents
Chromatography Research International
Volume 2011 (2011), Article ID 482308, 6 pages
http://dx.doi.org/10.4061/2011/482308
Research Article

Analysis of Chloramphenicol and Its Related Compound 2-Amino-1-(4-nitrophenyl)propane-1,3-diol by Reversed-Phase High-Performance Liquid Chromatography with UV Detection

1Faculty of Science and Technology, Al-Quds University, P.O. Box 20002, East Jerusalem, Palestine
2Research and Development Department, Jerusalem Pharmaceutical Co., P.O. Box 3570, Al-Bireh, Palestine

Received 18 May 2011; Revised 9 July 2011; Accepted 10 July 2011

Academic Editor: Wenkui Li

Copyright © 2011 Fuad Al-Rimawi and Maher Kharoaf. 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 and stability-indicating liquid chromatographic method is developed for the analysis of chloramphenicol and its related compound 2-amino-1-(4-nitrophenyl)propane-1,3-diol in two pharmaceutical forms. Liquid chromatography with a UV detector at a wavelength of 278 nm using a reversed phase C18 stationary phase has been employed in this study. Isocratic elution is employed using a mixture of sodium pentanesulfonate solution (0.012 M), acetonitrile, and glacial acetic acid (85 : 15 : 1, v/v). This new method is validated in accordance with USP requirements for new methods for assay determination, which include accuracy, precision, specificity, linearity and range. This method shows enough selectivity, sensitivity, accuracy, precision, and linearity range to satisfy Federal Drug Administration/International Conference on Harmonization regulatory requirements. The current method demonstrates good linearity over the range of 0.04–0.16 mg/mL of chloramphenicol. The accuracy of the method is 100.0% with a relative standard deviation of 0.1%. The precision of this method reflected by relative standard deviation of replicates is 0.1%. The method is sensitive with a detection limit of 0.005% for chloramphenicol. The related substance of chloramphenicol (2-amino-1-(4-nitrophenyl)propane-1,3-diol) can be selectively determined with a good resolution in two pharmaceutical forms: eye ointment and eye drops.