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Determination of levetiracetam in human plasma by liquid chromatography/electrospray tandem mass spectrometry and its application to bioequivalence studies.
Rapid Commun Mass Spectrom. 2006; 20(17):2539-47.RC

Abstract

The first liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the determination of levetiracetam, an antiepileptic drug, in human plasma is described. The plasma filtrate obtained after solid-phase extraction (SPE), using a polymer-based, hydrophilic-lipophilic balanced (HLB) cartridge, was submitted directly to a short column LC/MS/MS assay. There was no significant matrix effect on the analysis. For validation of the method, the recovery of the free analytes was compared to that from an optimized extraction method, and the analyte stability was examined under conditions mimicking sample storage, handling, and analytical procedures. The extraction procedure yielded extremely clean extracts with a recovery of 79.95% and 89.02% for levetiracetam and the internal standard (IS), respectively. The intra-assay and inter-assay precision for the samples at the lower limit of quantitation (LLOQ) were 6.33 and 6.82%, respectively. The calibration curves were linear for the dynamic range of 0.5 to 50 microg/mL with a correlation coefficient r >/= 0.9971. The intra-assay accuracy at LLOQ, LQC, MQC, and HQC levels ranged from 81.60 to 95.40, 93.00 to 103.47, 95.97 to 104.09, and 91.15 to 95.18%, respectively, while the inter-assay accuracy at LLOQ, LQC, MQC and HQC levels varied from 80.20 to 95.40, 88.53 to 107.53, 95.97 to 108.45, and 91.15 to 112.70%, respectively. The method is rugged and fast with a total instrumental run time of 2 min. The method was successfully applied for bioequivalence studies in human subject samples after oral administration of 1000 mg immediate release (IR) formulations.

Authors+Show Affiliations

Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380 009, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Validation Study

Language

eng

PubMed ID

16878346

Citation

Jain, Deepak S., et al. "Determination of Levetiracetam in Human Plasma By Liquid Chromatography/electrospray Tandem Mass Spectrometry and Its Application to Bioequivalence Studies." Rapid Communications in Mass Spectrometry : RCM, vol. 20, no. 17, 2006, pp. 2539-47.
Jain DS, Subbaiah G, Sanyal M, et al. Determination of levetiracetam in human plasma by liquid chromatography/electrospray tandem mass spectrometry and its application to bioequivalence studies. Rapid Commun Mass Spectrom. 2006;20(17):2539-47.
Jain, D. S., Subbaiah, G., Sanyal, M., Pal, U., & Shrivastav, P. S. (2006). Determination of levetiracetam in human plasma by liquid chromatography/electrospray tandem mass spectrometry and its application to bioequivalence studies. Rapid Communications in Mass Spectrometry : RCM, 20(17), 2539-47.
Jain DS, et al. Determination of Levetiracetam in Human Plasma By Liquid Chromatography/electrospray Tandem Mass Spectrometry and Its Application to Bioequivalence Studies. Rapid Commun Mass Spectrom. 2006;20(17):2539-47. PubMed PMID: 16878346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of levetiracetam in human plasma by liquid chromatography/electrospray tandem mass spectrometry and its application to bioequivalence studies. AU - Jain,Deepak S, AU - Subbaiah,Gunta, AU - Sanyal,Mallika, AU - Pal,Usha, AU - Shrivastav,Pranav S, PY - 2006/8/1/pubmed PY - 2007/10/5/medline PY - 2006/8/1/entrez SP - 2539 EP - 47 JF - Rapid communications in mass spectrometry : RCM JO - Rapid Commun Mass Spectrom VL - 20 IS - 17 N2 - The first liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the determination of levetiracetam, an antiepileptic drug, in human plasma is described. The plasma filtrate obtained after solid-phase extraction (SPE), using a polymer-based, hydrophilic-lipophilic balanced (HLB) cartridge, was submitted directly to a short column LC/MS/MS assay. There was no significant matrix effect on the analysis. For validation of the method, the recovery of the free analytes was compared to that from an optimized extraction method, and the analyte stability was examined under conditions mimicking sample storage, handling, and analytical procedures. The extraction procedure yielded extremely clean extracts with a recovery of 79.95% and 89.02% for levetiracetam and the internal standard (IS), respectively. The intra-assay and inter-assay precision for the samples at the lower limit of quantitation (LLOQ) were 6.33 and 6.82%, respectively. The calibration curves were linear for the dynamic range of 0.5 to 50 microg/mL with a correlation coefficient r >/= 0.9971. The intra-assay accuracy at LLOQ, LQC, MQC, and HQC levels ranged from 81.60 to 95.40, 93.00 to 103.47, 95.97 to 104.09, and 91.15 to 95.18%, respectively, while the inter-assay accuracy at LLOQ, LQC, MQC and HQC levels varied from 80.20 to 95.40, 88.53 to 107.53, 95.97 to 108.45, and 91.15 to 112.70%, respectively. The method is rugged and fast with a total instrumental run time of 2 min. The method was successfully applied for bioequivalence studies in human subject samples after oral administration of 1000 mg immediate release (IR) formulations. SN - 0951-4198 UR - https://www.unboundmedicine.com/medline/citation/16878346/Determination_of_levetiracetam_in_human_plasma_by_liquid_chromatography/electrospray_tandem_mass_spectrometry_and_its_application_to_bioequivalence_studies_ L2 - https://doi.org/10.1002/rcm.2623 DB - PRIME DP - Unbound Medicine ER -