Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF LEVETIRACETAM BY FORCED DEGRADATION STUDIES

Apurva N. Gaikwad*, Manjusha N. Dole and Akshay G. Ramphale

ABSTRACT

The present work describe development and validation of precise, accurate, sensitive and stability indicating high performance liquid chromatographic method for analysis of Levetiracetam in bulk and Pharmaceutical dosage form. The mobile phase used for separation is Methanol:Water(60:40v/v) using Hi Q sil C-18 (250 mm × 4.6 mm, 5 μm) column with the flow rate of 0.8ml/min. The detection was done at 215nm using PDA detector. The retention time of Levetiracetam was found to be 5.11 ±0.5min. Levetiracetam was subjected to stress conditions including acidic, alkaline, oxidation, Neutral hydrolysis, Photolytic stress conditions. This method was applied to pharmaceutical dosage form. Linearity was found to be 10-50μg/ml with significantly higher value of correlation coefficient (r2=0.9994). The method was validated for linearity, accuracy, precision, robustness and recovery. The limit of detection and limit of quantitation were found to be 0.226 μg/ml and 0.68μg/ml respectively.

Keywords: Levetiracetam, RP-HPLC, Antiepileptic, Forced degradation Validation.