DEVELOPMENT AND VALIDATION OF A HEADSPACE GAS CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF RESIDUAL SOLVENTS IN LEVETIRACETAM (API)

Levetiracetam is a new antiepileptic medication that is effective as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. It is the S-enantiomer of etiracetam, structurally similar to the prototypical nootropic drug piracetam. Levetiracetam shows great potential as a safe and effective agent for the treatment of neonatal seizures based on its efficacy and safety profile in other age groups, its mechanism of action is still not much known.

 Materials and Methods: The method development and its validation were performed on Agilent’s gas chromatographic system equipped with Flame Ionization detector and head space analyzer. The method involved in SPB^TM– 624, Supelco, 60 m length, 0.32 mm internal diameter, and 1.8 µm film thickness column using nitrogen gas as a carrier. The flow rate was 1.5 mL per minute and flame ionization detector (FID) was used.

Results: During method validation, parameters such as precision, linearity, accuracy, limit of quantification and detection and specificity were evaluated, which remained within acceptable limits.

Conclusions: The method has been successfully applied for the quantification of the amount of residual solvents present in Levetiracetam bulk drug. The method presents a simple and reliable solution for the routine quantitative analysis of residual solvents in Levetiracetam bulk drug.