Abstract

Validated stability-indicating methods for determination of Levetiracetam

Author(s): A.E.El-Gendy, M.A.Mohamed, O.Abd El-Aziz, R.Mahmoud

New simple, accurate, rapid and reproducible methods have been developed and subsequently validated for the determination of Levetiracetam in presence of its acidic and alkaline-degradates, as stability-indicating studies. In the first method, two novel methods were adopted by utilizing zerocrossing technique, where the investigated drug was determined in presence of its both-degradates, by the use of third derivative (D3) and second derivative ratio spectrophotometry (DR2), respectively. The second method was isocratic reversed-phase (RP) stability-indicating high-performance liquid chromatographic (HPLC)method, whichwas adopted for determination of Levetiracetamin presence of its acidic and alkaline-degradates. The chromatographic separation was achieved isocratically using a mobile phase of acetonitrile:water (10:90, v/v), with 0.06%triethylamine and pHadjusted to 2.5 using orthophosphoric acid. The analysis was carried out usingAgilent eclipseXDB C18 column (150mmï‚´ 4.6mm, 5 µm) at flow rate of 1 ml.min-1 and the UV detection at 205 nm. All the proposed methods were validated according to the International Conference on Harmonization (ICH) guidelines and successfully applied for determination of the Itopride Hydrochloride in pure form, in laboratory prepared mixtures and in pharmaceutical preparations. The obtained results were statistically compared to the reported method of analysis for Levetiracetam and no significant differences were found with respect to accuracy and precision.