Stability indicating RP-HPLC method for estimation of levetiracetam in pharmaceutical formulation and application to pharmacokinetic study

A stability-indicating HPLC method was developed and validated for the quantitative determination of Levetiracetam in tablet dosage forms. The separation was achieved using a Phenomenex 250 mm × 4.6 mm i.d., 5 μm particle size C18 column. Mobile phase containing a mixture of Methanol, water and Acetonitrile (30:10:60 v/v) was pumped at a flow rate of 1.0 mL/min. UV detection was performed at 212 nm. The drug was subjected to acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation. Complete seperation of degraded product was achieved from parent compound. The chromatographic analysis time was approximately 7 min per sample with complete resolution of Levetiracetam (t_R = 5.351 min) from the major degradation products. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The calibration plots were linear over the concentration ranges 0.01 – 1.5 μg/mL with limit of detection of 0.005 μg/mL and limit of quantification 0.01 μg/mL for Levetiracetam. The developed method was successfully applied for the precise analysis of the studied drug in its pharmaceutical dosage form. The mean percentage recovery was found to be 99.86 ± 0.4206 for levetiracetam. As the method could effectively separate the drug from its degradation products, it can be employed for analysis of stability samples. The developed method has been successfully applied for chemical kinetic study. The study shows zero order degradation behaviour.

Author(s): Jignesh S. Shah, G. Vidyasagar and H. Barot

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