Analytical Method Development and Validation for the Determination of Levetiracetam in Bulk and Pharmaceutical Formulation by Rp-HPLC

Abstract

This study describes the development and validation for levetiracetam tablets using a reverse phase high performance liquid chromatography method. A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for estimation of anti-epileptic drug, levetiracetam in raw material and its tablet dosage form. Separation was done by using mobile phase consisting of HPLC grade methanol.The separations were carried out on a Flexit C18 column (150 x 4.6 mm; 5µm) at a flow rate of 1 mL/min. The injection volume was 20 µl and the peaks were detected at 265 nm. The linear dynamic response was found to be in the concentration range of 5µg-25µg/mL and coefficient of correlation was found to be 0.999. The %RSD value was below 2.0 for intraday and interday precision indicated that the method was highly precise. The LOD and LOQ were found to be 4.23 and 12.65 ng/mL respectively which revealed that the method was highly sensitive. The percentage recovery value was higher than 100%, indicating the accuracy of the method and absence of interference of the excipients present in the formulation. The proposed method was simple, fast, accurate, precise and reproducible and hence can be applied for routine quality control analysis of levetiracetam in bulk and pharmaceutical formulation.