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Quantification of levetiracetam in human plasma by liquid chromatography-tandem mass spectrometry: application to therapeutic drug monitoring.
J Pharm Biomed Anal. 2008 Nov 04; 48(3):822-8.JP

Abstract

A rapid, selective, reliable, precise, accurate, and reproducible tandem mass spectrometric (MS-MS) method for the quantification of levetiracetam (LEV) in human plasma using adenosine as an internal standard (IS) has been developed and validated. The drug and IS were extracted by solid phase extraction (SPE) technique and analyzed on Symmetry((R)) C(18) column (5 microm, 3.9 mm x 50 mm) using a mobile phase of methanol-water-formic acid (97:03:0.25, v/v/v) at a flow rate of 0.2 ml/min. Quantitation was achieved using a positive electrospray ionization (ESI+) interface employing multiple reaction monitoring (MRM) mode at MRM transitions m/z 171>126 and m/z 268>136 for LEV and IS, respectively. The method was validated over the concentration range of 1.0-40 microg/ml (r>0.99) with a limit of quantification of 1.0 microg/ml (R.S.D.%; 4.1 and Bias%; -9.0 to + 11.0%). Intra- and inter-run precision of LEV assay at three concentrations ranged from 0.6 to 8.9% with accuracy (bias) varied from -4.0 to 8.6% indicating good precision and accuracy. Analytical recoveries of LEV and IS from spiked human plasma were in the range of 91.7-93.4% and 80.2-84.1%, respectively. Stability of LEV in human plasma samples at different conditions showed that the drug was stable under the studied conditions. Matrix effect study showed a lack of matrix effect on mass ions of LEV and IS. The described method compared well with the commercial HPLC-UV method of Chromsystem (r(2)=0.99). The suitability of the developed method for therapeutic drug monitoring was demonstrated by measuring LEV in human plasma samples of epileptic patients treated with LEV.

Authors+Show Affiliations

Department of Applied Therapeutics, Faculty of Pharmacy, Kuwait University, Safat, Kuwait. kamal@hsc.edu.kw

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18603399

Citation

Matar, Kamal M.. "Quantification of Levetiracetam in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry: Application to Therapeutic Drug Monitoring." Journal of Pharmaceutical and Biomedical Analysis, vol. 48, no. 3, 2008, pp. 822-8.
Matar KM. Quantification of levetiracetam in human plasma by liquid chromatography-tandem mass spectrometry: application to therapeutic drug monitoring. J Pharm Biomed Anal. 2008;48(3):822-8.
Matar, K. M. (2008). Quantification of levetiracetam in human plasma by liquid chromatography-tandem mass spectrometry: application to therapeutic drug monitoring. Journal of Pharmaceutical and Biomedical Analysis, 48(3), 822-8. https://doi.org/10.1016/j.jpba.2008.05.035
Matar KM. Quantification of Levetiracetam in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry: Application to Therapeutic Drug Monitoring. J Pharm Biomed Anal. 2008 Nov 4;48(3):822-8. PubMed PMID: 18603399.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantification of levetiracetam in human plasma by liquid chromatography-tandem mass spectrometry: application to therapeutic drug monitoring. A1 - Matar,Kamal M, Y1 - 2008/06/03/ PY - 2008/01/11/received PY - 2008/05/20/revised PY - 2008/05/21/accepted PY - 2008/7/8/pubmed PY - 2009/2/27/medline PY - 2008/7/8/entrez SP - 822 EP - 8 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 48 IS - 3 N2 - A rapid, selective, reliable, precise, accurate, and reproducible tandem mass spectrometric (MS-MS) method for the quantification of levetiracetam (LEV) in human plasma using adenosine as an internal standard (IS) has been developed and validated. The drug and IS were extracted by solid phase extraction (SPE) technique and analyzed on Symmetry((R)) C(18) column (5 microm, 3.9 mm x 50 mm) using a mobile phase of methanol-water-formic acid (97:03:0.25, v/v/v) at a flow rate of 0.2 ml/min. Quantitation was achieved using a positive electrospray ionization (ESI+) interface employing multiple reaction monitoring (MRM) mode at MRM transitions m/z 171>126 and m/z 268>136 for LEV and IS, respectively. The method was validated over the concentration range of 1.0-40 microg/ml (r>0.99) with a limit of quantification of 1.0 microg/ml (R.S.D.%; 4.1 and Bias%; -9.0 to + 11.0%). Intra- and inter-run precision of LEV assay at three concentrations ranged from 0.6 to 8.9% with accuracy (bias) varied from -4.0 to 8.6% indicating good precision and accuracy. Analytical recoveries of LEV and IS from spiked human plasma were in the range of 91.7-93.4% and 80.2-84.1%, respectively. Stability of LEV in human plasma samples at different conditions showed that the drug was stable under the studied conditions. Matrix effect study showed a lack of matrix effect on mass ions of LEV and IS. The described method compared well with the commercial HPLC-UV method of Chromsystem (r(2)=0.99). The suitability of the developed method for therapeutic drug monitoring was demonstrated by measuring LEV in human plasma samples of epileptic patients treated with LEV. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/18603399/Quantification_of_levetiracetam_in_human_plasma_by_liquid_chromatography_tandem_mass_spectrometry:_application_to_therapeutic_drug_monitoring_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(08)00329-4 DB - PRIME DP - Unbound Medicine ER -