ISSN : 2663-2187

Robust Stability Indicating Analytical Method for Levetiracetam in Tablet Dosage Form

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Vijaya Lakshmi Marella , Suneetha Achanti , InduriMadhu Sudhan Reddy , Kanaka Durga Devi Nelluri , Kiranmai seelam , Chetan Mokkapati , Kolaventi BhuvanaLekha
» doi: 10.48047/AFJBS.6.13.2024.5634-5644

Abstract

A novel and highly selective reverse phase liquid chromatography (HPLC) method was optimised for quantifying levetiracetam in pharmaceutical formulations. The chromatographic resolution was achieved using a Symmetry C18 column (4.6 mm × 250 mm, 5 μm particle size) and a mobile phase consists of 0.1% formic acid in 70% aqueous solution and 30% methanol, flowing for 1.0 mL/min. Detection was performed at 210 nm. The full run time for the analysis was six minutes, and the retention time observed for levetiracetam was 4.405 minutes. Peak purity analysis conducted under all degradation conditions confirmed the homogeneity of the peak, thereby establishing the method as stability-indicating. The results of validation parameters demonstrated that the procedure exhibits linearity, precision, accuracy, reproducibility, and selectivity for the analysis of levetiracetam.All obtained results met acceptance criteria, confirming the acceptability of the approach for routine analytical control and drug assay purposes.

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