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Application Brief

HPLC Analysis of Levetiracetam Using Epic C18, Epic C18-SD, and Epic Polar Columns in Accordance with the USP

Introduction

Levetiracetam was approved for medical use in the United States in 1999 and is available as a generic medication.1 Levetiracetam is a novel anticonvulsant agent used as an adjunct medication to manage partial onset, myoclonic, and generalized tonic-clonic seizures in patients with epilepsy. It is sold under the brand name Keppra, among others, and is a medication used to treat epilepsy. It is used for partial-onset, myoclonic, or tonic–clonic seizures and is taken either by mouth as an immediate or extended-release formulation or by injection into a vein. In 2018, it was the 97th most prescribed medication in the United States, with more than 7 million prescriptions. Levetiracetam is also available as an orally dissolvable tablet that is indicated as an adjunct in the treatment of partial onset seizures in patients with epilepsy who are 4 years of age and older and weigh more than 20 kg. Levetiracetam is being tested as a drug to reduce hyperactivity in the hippocampus in Alzheimer's disease.

The United States Pharmacopeia (USP) provides monographs for identification and impurity testing of the drug substance. This application brief describes use of an Epic C18, Epic C18 SD column (highly base deactivated high carbon super dense phase), and Epic Polar (all USP L1 columns) coupled with the LC 300 liquid chromatography system and SimplicityChrom chromatography data system (CDS) for the analysis of Levetiracetam as per the USP monograph.