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Development of a validated stability-indicating high-performance thin-layer chromatographic method for the quantification of levetiracetam
P BHATTACHARYA, M GHOSH, A CHATTERJEE, S BANGAL,
Published in Research Institute for Medicinal Plants
2014
Volume: 27
   
Issue: 2
Pages: 132 - 139
Abstract
Levetiracetam (LT) is an FDA-approved orally active anticonvulsant drug. A high-performance thin-layer chromatographic (HPTLC) method for the analysis of LT in a tablet formulation has been developed and validated. Separation is performed on silica gel 60 F with toluene-ethyl acetate-methanol, 2:1:1 (v/v/v) as mobile phase. Densitometric evaluation of the separated zone is carried out at 204 nm. There is no chromatographic interference from the tablet excipients, and compact spots are observed for LT (R=0.50 ± 0.02). Regressional analysis of the calibration plot revealed good linearity over the concentration range of 0.1-1.0 μg/mL. The method is validated for linearity, precision, robustness, and recovery in accordance with ICH guidelines. The LOD and LOQ were found to be 0.03 and 0.1 μg/spot, respectively. Stability was checked under acidic, alkaline, and aquatic environmental stress conditions. The drug was found to be more than 65% undegraded after 14 days of study. The developed method might be useful in the quality control of LT in the pharmaceutical industry and environmental toxicity assessments.
About the journal
JournalJournal of Planar Chromatography - Modern TLC
PublisherResearch Institute for Medicinal Plants
ISSN0933-4173
Open AccessNo