Table of Contents
Chromatography Research International
Volume 2012, Article ID 273604, 6 pages
http://dx.doi.org/10.1155/2012/273604
Research Article

Development and Validation of a Stability-Indicating HPTLC Method for Analysis of Rasagiline Mesylate in the Bulk Drug and Tablet Dosage Form

1Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur 522002, India
2Department of Chemical Engineering, JNTU College of Engineering, Anantapur 515002, India
3Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada 520008, India

Received 2 May 2011; Revised 18 July 2011; Accepted 2 October 2011

Academic Editor: Wenkui Li

Copyright © 2012 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

A simple and sensitive thin-layer chromatographic method has been established for analysis of rasagiline mesylate in pharmaceutical dosage form. Chromatography on silica gel 60 F254 plates with 6 : 1 : 2(v/v/v) butanol-methanol water as mobile phase furnished compact spots at   . Densitometric analysis was performed at 254 nm. To show the specificity of the method, rasagiline mesylate was subjected to acid, base, neutral hydrolysis, oxidation, photolysis, and thermal decomposition, and the peaks of degradation products were well resolved from that of the pure drug. Linear regression analysis revealed a good linear relationship between peak area and amount of rasagiline mesylate in the range of 100–350 ng/band. The minimum amount of rasagiline mesylate that could be authentically detected and quantified was 11.12 and 37.21 ng/band, respectively. The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness. Since the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.