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Development and validation of a novel stability-indicating lc method for the determination of riluzole in bulk drug and tablets

Chromatographia, ISSN: 0009-5893, Vol: 69, Issue: 5-6, Page: 513-517
2009
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Article Description

A novel stability indicating LC method was developed and validated for the quantitative determination of riluzole in bulk drugs and in pharmaceutical dosage forms in the presence of its isomers, related substances and degradation products. The drug was subjected to stress conditions of hydrolysis (acid, base and neutral), oxidation, photolysis and thermal degradation. Considerable degradation was observed under base hydrolysis and oxidation. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed method was validated with respect to linearity, accuracy, precision, specificity, ruggedness and robustness. © 2008 Vieweg+Teubner | GWV Fachverlage GmbH.

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