Table of Contents
Chromatography Research International
Volume 2013, Article ID 941429, 6 pages
http://dx.doi.org/10.1155/2013/941429
Research Article

Stress Degradation Studies on Flupirtine Maleate Using Stability-Indicating RP-HPLC Method

Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur 522002, India

Received 2 September 2013; Accepted 31 October 2013

Academic Editor: Toyohide Takeuchi

Copyright © 2013 Singaram Kathirvel 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

With the objective of developing an advanced method for rapid separation with shorter runtime, a simple, precise, and accurate stability-indicating isocratic RP-LC method coupled with PDA detector was developed for the quantitative determination of flupirtine maleate in bulk and in capsule dosage form. Good resolution between the peaks for degradation products and the analyte was achieved on a Waters Agilent XDB C18 (  mm, 5 μm) column using mobile phase containing a mixture of phosphate buffer pH 3.36 and acetonitrile in the ratio of 65 : 35. The eluted compounds were monitored at 344 nm and the flow rate employed for the present investigation was 1 mL/min. The newly developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness. The method may be employed for the assay determination of flupirtine maleate in pharmaceutical dosage forms.