Development and Validation of Stability-Indicating HPLC Method for the Quantification of Levetiracetam in Bulk and Oral Solution: Application to Chemical Kinetics

In the present study, a simple, accurate, precise and specific stability-indicating LC method was developed and validated for the quantification of levetiracetam (LEV) in bulk and oral solution. LEV and its degradation products were separated and resolved successfully on C18 column using a methanol:water (30:70 %, v/v) mixture in the isocratic mode at a flow rate of 1 mL/min. All eluents were detected at 205 nm. In forced degradation experiments, LEV was found to degrade significantly in acid, alkali, wet heat, peroxide mediated oxidation, and photolytic conditions, and found stable under dry heat conditions. Validation experiments showed acceptable accuracy, precision, and specificity of the developed method. Assay of the oral solution was in good agreement with the amount of LEV as per the label claim. The method was applied to investigate chemical kinetics under acid and alkali hydrolysis and the pH rate profile of LEV within a range of pH 2 – 12.