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Bioanaltical Method Development And Validation Of Levetiracetam In Rat Plasma By K3edta Using Lc-Ms/Ms.
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| Author:
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KHEDKAR AMOL NAVNATH, DR.S.SATHESH KUMAR
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| Abstract:
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Levetiracetam is a broad-spectrum antiepileptic drug with IUPAC name was (2S)-2-(2-oxopyrrolidin-1-yl) butanamide, having logP 0.64, and available dose of marketed formulation was 250 mg, 500 mg, 750 mg and half-life of 6-8 hours. Drug Stock Solution for Levetiracetam 10.000 mg/ml prepared and SS Concentrations 250000.000 ng/mL to 250.000 ng/mL for STD1 to STD9 respectively prepared and for QC Samples 200000.000 ng/mL to 250.000 ng/mL for HQC to LLOQ QC respectively, different trials were taken for optimization of chromatographic condition and mobile phase finalized was 10 mM Ammonium Acetate in Water: Acetonitrile (30:70). The stationary phase used was Gemini C18 column shows good response and good chromatography at Rt 4.3 for Levetiracetam. For extraction process P.V. 100 µl + 500 µl 2.0 % Formic Acid in Water + Conditioning (1ml Methanol+1 ml Water) + Loading + Washing (1 ml Water + 1 ml 5 % Methanol in Water) + Elution with Acetonitrile was selected on the basis of good response and good chromatography was observed at each level by using Extraction Cartridge as Strata-X 33µ (30mg/1ml). All the results were found within the acceptance criteria, and method developed and validated as per protocol successfully.
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| Keyword:
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Levetiracetam, Anti-Epileptic, validation.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.523
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| Download:
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