Estimation of Levetiracetam in Human K2EDTA Plasma in range from 0.253 µG/ML to 35.060 µG/ML by using LC-MS/MS

Narendra Kumar Reddy Kolli*, Swetha Polagani, Sandhya, Rathnakar Nathi²
Sri Vani School of Pharmacy, Chevuturu, Vijayawada, AP. India
Wuxi DEE Pharmaceuticals Ltd. Xishan District, Wuxi, Jiangsu province, PRChina

A B S T R A C T
A simple, sensitive and selective method for the determination of Levetiracetam by using rapid high-performance liquid chromatography/positive electroscopy ionization tandem mass spectroscopy was developed. The method consists of precipitation extraction with Acetonitrile followed by the analysis of the extracted sample by liquid chromatography-mass spectroscopy (LC-MS/MS) in selective reaction monitoring mode using electrospray ionization mode (ESI). Chromatography was performed on a C₁₈ reverse phase column, Methanol: Acetonitrile: 10mM ammonium acetate (45:45:10) as a mobile phase. The assay exhibited a linear dynamic range of 1 to 40µg/ml for Levetiracetam in human plasma. Stability assessment was also included. A run time of 3.0 min for each sample made it possible to analyse healthy volunteers participating in pharmacokinetics drug-drug interaction studies.
Keywords: LC-MS/MS, Human Plasma, Bioanalytical, Levetiracetam, Validation.