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Journal of Analytical Methods in Chemistry
Volume 2015, Article ID 835986, 5 pages
http://dx.doi.org/10.1155/2015/835986
Research Article

Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms

Service Pharmacie, Hôpital Jean-Verdier, Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires de Paris-Seine-Saint-Denis, avenue du 14 Juillet, 93140 Bondy, France

Received 4 September 2015; Accepted 7 October 2015

Academic Editor: Vito Verardo

Copyright © 2015 Sonoube Kombath 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 stability-indicating method was validated for the determination in pharmaceutical forms of idebenone a coenzyme Q10-like compound. The assay was achieved by liquid chromatography analysis using a reversed-phase C18 column and a detector set at 480 nm. The optimized mobile phase consisted of isocratic flow rate at 1.0 mL/min for 3 min with methanol. The linearity of the assay was demonstrated in the range of 3.0 to 8.0 mg/mL with a correlation coefficient . The limits of detection and quantification were 0.03 and 0.05 mg/mL, respectively. The intraday and interday precisions were less than 1.0%. Accuracy of the method ranged from 98.6 to 101.5% with RSD < 0.6%. Specificity of the assay showed no interference from tablets components and breakdown products formed by alkaline, acidic, oxidative, sunlight, and high temperature conditions. This method allows accurate and reliable determination of idebenone for drug stability assay in pharmaceutical studies.