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Background: Levetiracetam is an antiepileptic drug prescribed in the treatment of patients with seizures. This study aimed to develop a bioanalytical (HPLC) high performance liquid chromatography method for monitoring drug plasma levels in subjects with levetiracetam and pantoprazole as comedication. Method: A Bioanalytical Method Development and Validation were done through High Performance Liquid Chromatography was developed to analyze the plasma level concentration of levetiracetam in subjects. The plasma concentrations were analyzed in 65 epileptic subjects given 250 to 1000 mg/dose of levetiracetam ranging in males 4550.72ng/mL and females 2586.48ng/mL. Results: The validation parameters were processed as ICH guidelines with linearity of levetiracetamwhereY=57.978X+6.6141andforpantoprazoleY=20.047X+102followedwith Inter dayandintradayprecisionon250ng/ml,450ng/ml,650ng/mlforlevetiracetamwhere %RSD are 0.02,0.09,0.03,0.02,0.07 and 0.02 respectively, where the pantoprazole %RSD are 0.05,0.02,0.01,0.02,0.05, and0.03respectively. Therapeutic Drug Monitoring for levetiracetam with pantoprazole as comedication showed significant results where the mean serum concentration for 65 subjects who undergoing medication for period of time with achieved steady state serum concentration. The therapeutic range was found to be 25 male and 12 female subjects, further 28 subjects of both genders were under sub-therapeutic activity with no dose correction requirement. Conclusion: The method proposed to measure levetiracetam concentration was convenient, reproducible, and specific. Therefore, randomized, controlled studies in a larger population are awaited with a wide range of dosing (2501000mg) to correlate with the total serum concentration of the population and multiple comedications for dose adjustments to maintain the maximum safe concentration in the subject. |
