Table of Contents
International Scholarly Research Notices
Volume 2014 (2014), Article ID 481059, 7 pages
http://dx.doi.org/10.1155/2014/481059
Research Article

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Department of Pharmaceutics, Faculty of Pharmacy, Islamic Azad University (IAUPS), Pharmaceutical Sciences Branch, Tehran 193956466, Iran

Received 5 June 2014; Accepted 30 July 2014; Published 23 October 2014

Academic Editor: Josep Esteve-Romero

Copyright © 2014 Roghaieh Khoshkam and Minoo Afshar. 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 rapid and stability-indicating RP-HPLC method was developed for determination of L-carnitine in tablets. The separation was based on a C18 analytical column using a mobile phase which consisted of 0.05 M phosphate buffer (pH = 3): ethanol (99 : 1), including 0.56 mg/mL of sodium 1-heptanesulfonate. Column temperature was set at 50°C and quantitation was achieved by UV detection at 225 nm. In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat. Among the different stress conditions, the exposure to acidic and basic conditions was found to be an important adverse stability factor. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The applied procedure was found to be linear in L-carnitine concentration range of 84.74–3389.50 µg/mL . Precision was evaluated by replicate analysis in which relative standard deviation (RSD) values for areas were found below 2.0%. The recoveries obtained (100.83%–101.54%) ensured the accuracy of the developed method. The expanded uncertainty (3.14%) of the method was also estimated from method validation data. Accordingly, the proposed validated and rapid procedure was proved to be suitable for routine analyzing and stability studies of L-carnitine in tablets.