Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation.

ABSTRACT

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 301060. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm ( max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation studies. The standard calibration curve was plotted for the drug and results showed that the drug was linear (r2 = 0.999) in the concentration range between 0.01 – 1.5 μg/ml. The results of stress testing undertaken according to the International Conference on Harmonization (ICH) guidelines reveal that the selected method is selective and stability-indicating for determination of levitiracetam in pharmaceutical formualtion.