Validated Stability-Indicating LC Method for Zonisamide

A simple, isocratic, rapid, and accurate reversed-phase high-performance liquid chromatographic method has been established for quantitative determination of zonisamide. The method is also applicable to determination of related substances in the bulk drug. Chromatographic separation was achieved on...

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Bibliographic Details
Published in:Chromatographia 2007-12, Vol.66 (11-12), p.945-947
Main Authors: Pathare, Dnyandeo B, Jadhav, Ashok S, Shingare, Murlidhar S
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Forced degradation and validation
General pharmacology
liquid chromatography
Medical sciences
Pharmacology. Drug treatments
Zonisamide
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Summary:A simple, isocratic, rapid, and accurate reversed-phase high-performance liquid chromatographic method has been established for quantitative determination of zonisamide. The method is also applicable to determination of related substances in the bulk drug. Chromatographic separation was achieved on a 250 mm x 4.6 mm, 5-μm particle, C₁₈ column; the mobile phase was a 70:30 (v/v) mixture of 0.1% (v/v) aqueous triethylamine, adjusted to pH 2.5 with dilute orthophosphoric acid, and acetonitrile. Chromatographic resolution of zonisamide from its potential impurity, A, was found to be >2. The limits of detection and quantification of zonisamide and impurity A were 0.04 and 0.12 μg mL-¹, respectively, for 20 μL injection volume. Recovery of zonisamide ranged from 98.5 to 101.2% and recovery of impurity A from a sample of zonisamide ranged from 97.4 to 102.7%. The method was validated for linearity, accuracy, precision, and robustness.
ISSN:0009-5893
1612-1112
DOI:10.1365/s10337-007-0421-5