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

M. Krishna Chaitanya Prasad, G. Vidhya Sagar, P. Sudhakar

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 30:10:60. 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 (λ 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.

Keywords


Levitiracetam, Stability studies, Impurities.

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DOI: https://doi.org/10.30750/ijpbr.1.4.9

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