A VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF LEVETIRACETAM IN BULK AND PHARMACEUTICAL FORMULATION

*Likhitha T. G., Jose Gnana Babu C. and Sowmya H. G.

ABSTRACT

A new sensitive, specific, linear, precise and accurate RP-HPLC method was developed and validated for estimation of Levetiracetam in Bulk and Pharmaceutical Tablet Formulations. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, Phenomenex Gemini 5μ C18 (2) 100A (250 x 4.60mm, 5 μ) column. Hamilton syringe (705 NR, 50 μL) was used for injecting sample and standard solution. Data was compiled using Spinchrom software. Mobile phase consists of mixture of Methanol:Acetonitrile in the ratio (90:10 v/v) at a flow rate of 1.0 mL /min. UV detection was performed at 210 nm. The Linearity was established for Levetiracetam in the range of 5- 30μg/ml with correlation coefficient of 0.9997. LOD and LOQ were found to be 0.076μg/ml and 0.23μg/ml respectively. Retention time of Levetiracetam were found to be 2.281min and 2.274min. % Recovery was found to be 99.78-100.45 and %RSD was found with in ± 2. The method has been validated according to ICH guidelines for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed validated method was successfully applied for reliable quantification of Levetiracetam in bulk and pharmaceutical dosage form.

Keywords: Levetiracetam, RP- HPLC, validation, pharmaceutical formulations.