Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LEVETIRACETAM BY UHPLC

S. Pracitha*, K. L. Senthil kumar, P. D. Gokulan

ABSTRACT

It is a fast-validated method for the determination of anti-convulsant drug Levetiracetam for method development and validation using Ultra High-Performance Liquid Chromatography (UHPLC). Levetiracetam is a pyrrolidone family antiepileptic drug with with broad spectrum of activity. This method is used predominately to identify, quantify and separate components of a mixture by using high pressure to push solvents through the column. In UHPLC, particle sizes less than 2um can be used, providing better separation than HPLC where particle size is limited to 5um. These smaller particles require higher pump pressures (100MPa vs.40 MPa, making this technique very efficient with fast analysis and higher resolution. UHPLC separations produce very narrow peaks (1 to 3 s at the base, or 10 to 30 μL in volume for a 2.1 mm x 50 mm, 1.7 um column). This method was validated as per the ICH guidelines and can be used for routine analysis of Levetiracetam in the rapid and reliable determination of Levetiracetam in Tablet formulation.

Keywords: the ICH guidelines and can be used for routine analysis of Levetiracetam in the rapid and reliable determination of Levetiracetam in Tablet formulation.