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. 2015:2015:835986.
doi: 10.1155/2015/835986. Epub 2015 Oct 29.

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

Sonoube Kombath  1 , Issa-Bella Balde  1 , Sandra Carret  1 , Sofiane Kabiche  1 , Salvatore Cisternino  1 , Jean-Eudes Fontan  1 , Joël Schlatter  1
Affiliations

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

Sonoube Kombath et al. J Anal Methods Chem. 2015.

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 r (2) > 0.998. 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.

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Figures

Figure 1
Figure 1
Chemical structure of idebenone.
Figure 2
Figure 2
Representative HPLC chromatogram of idebenone standard (4 mg/mL) in methanol mobile phase; flow rate: 1.0 mL/min; detection wavelength: 480 nm; column temperature: 25 ± 3°C; and injection volume: 25 μL.
Figure 3
Figure 3
HPLC chromatograms obtained from excipients compounded from tablets.
Figure 4
Figure 4
Chromatograms of 1 N HCl (a), 1 N NaOH (b), and oxidative (c) stress conditions.
See this image and copyright information in PMC

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