Table of Contents
ISRN Analytical Chemistry
Volume 2012, Article ID 586415, 7 pages
http://dx.doi.org/10.5402/2012/586415
Research Article

Stability Indicating Method for Simultaneous RP HPLC Determination of Camylofin Dihydrochloride and Nimesulide in Pharmaceutical Preparations

1Department of Chemistry, B.N. Bandodkar College of Science, Thane-400 601, India
2Analytical Development Department, Versapharm Incorporated, 1035 Louis Drive, Warminster, PA 18974, USA

Received 16 September 2011; Accepted 16 October 2011

Academic Editors: P. Campíns-Falcó, A. Niazi, and A. Przyjazny

Copyright © 2012 Rajeev Kumar R. Singh 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, fast, and precise reversed phase high-performance liquid chromatographic method has been developed for the simultaneous determination of camylofin dihydrochloride and nimesulide using caffeine as an internal standard. The stability indicating capability of the method was proved by subjecting the drugs to stress conditions as per ICH-recommended test conditions. Separation was achieved using Varian Chromspher 5 C 1 8 column (250 mm × 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of buffer solution pH 5.0 : methanol (600 : 400, v/v) at a flow rate of 1.0 mL  m i n 1 , column temperature of 3 0 C and UV detection at 220 nm. The retention time of caffeine, camylofin dihydrochloride, and nimesulide was about 5.0 min, 6.1 min, and 12.7 min, respectively. The proposed method was validated for linearity, accuracy, precision, sensitivity, robustness and solution stability. Linearity, accuracy, and precision were found to be acceptable over the ranges of 250–750 μg  m L 1 for Nimesulide and 125–375 μg  m L 1 for camylofin dihydrochloride. The test solution was found to be stable for 72 h. It can be conveniently adopted for routine quality control analysis.