Development and validation of a GC/MS method for the simultaneous determination of levetiracetam and lamotrigine in whole blood

Νικολάου, Παναγιώτα; Papoutsis, Ioannis; Dona, Artemisia; Spiliopoulou, Chara; Athanaselis, Sotiris

doi:10.1016/j.jpba.2014.08.034

Cited by 33 publications

(14 citation statements)

References 24 publications

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“…Studies for the determination of levetiracetam in human plasma [13][14][15][16][17] are sparse. LC with ultraviolet detection [13,14], LC-photodiode array detection [15], GC-MS [16], and LC-tandem MS [17][18][19][20][21][22][23] methods have been developed for the determination of levetiracetam.…”

Section: Discussionmentioning

confidence: 99%

“…Various analytical techniques (HPLC, CE, and GC) are typically used for the separation of drugs, and among them, HPLC is the most common approach [11,12]. Despite the importance, there are few analytical methods reported for the determination of levetiracetam in human plasma [13][14][15][16][17][18][19][20][21][22][23]. Further, online heart-cutting LC methods have not been reported for the determination of levetiracetam in plasma.…”

Section: Introductionmentioning

confidence: 99%

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Determination of levetiracetam in human plasma by online heart‐cutting liquid chromatography: Application to therapeutic drug monitoring

Önal¹,

Kul

Ozdemir

et al. 2020

J of Separation Science

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Levetiracetam is an antiepileptic drug for the treatment of psychiatric patients. In this study, a selective, straightforward, and rapid online heart‐cutting liquid chromatography method was developed for the therapeutic drug monitoring of levetiracetam. This method allows for the determination of levetiracetam in human plasma without complex sample preparation. The mobile phases consisted of 30 mM aq. orthophosphoric acid solution/methanol (70:30) at a flow rate of 1 mL/min for the first system and 10 mM aq. orthophosphoric acid solution/methanol (55:45) at a flow rate of 1 mL/min for the second system. The first separation was carried out on a GL Sciences Intersil ODS‐3 column (4.6 mm × 150 mm, 3 µm) and the second separation was carried out on a Restek Ultra PFPP column (4.6 mm × 150 mm, 5 µm). The detection was carried out at 205 nm for both systems. The method was validated for selectivity and linearity, which were in the 6–60 µg/mL range. Intra‐ and interassay accuracies were <112.6%, and the intra‐ and interassay precisions were <6.4% for all quality control samples. The lower limit of quantitation was 6 µg/mL. The developed method was successfully applied for therapeutic drug monitoring of plasma samples from patients.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Determination of levetiracetam in human plasma by online heart‐cutting liquid chromatography: Application to therapeutic drug monitoring

Önal¹,

Kul

Ozdemir

et al. 2020

J of Separation Science

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“…Most patients achieve therapeutic benefit with serum drug concentrations between 6 and 46 μg/mL; the drug has a narrow therapeutic index, and there is risk of toxicity with levels exceeding this range or decreased effectiveness below the lower limit of the reference range. Previously, several methods were developed and validated to measure levetiracetam levels in circulation, which include liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry methods and a spectrometric method for measuring levetiracetam in tablets (6)(7)(8)(9). Furthermore, an automated enzyme immunoassay has been validated on other chemistry auto-analyzer platforms (10)(11)(12).…”

Section: Impact Statementmentioning

confidence: 99%

Validation of an Automated Assay for Levetiracetam (Keppra) on Vitros 5600

Ali

Tam

Roper

et al. 2017

The Journal of Applied Laboratory Medicine

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Objective Levetiracetam (also known as Keppra™) is an antiepileptic drug that has been demonstrated as an effective adjunctive therapy in the treatment of partial onset of seizures, primary generalized tonic-clonic seizures, and myoclonic seizures. The aim of our study was to validate an automated quantitative immunoassay for levetiracetam at Texas Children's Hospital. Method We validated the analytical performance of ARK™ Levetiracetam Assay on an Ortho Clinical Diagnostic Vitros 5600 Analyzer at Texas Children's Hospital. Analytical performance parameters included precision, linearity, sensitivity, accuracy, and effect of common interferents (free hemoglobin, bilirubin, triglycerides). We also tested common drug interferents on the ARK Levetiracetam Assay. Results The assay showed good precision with <4% coefficient of variation (%CV) for intraassay and <7% for interassay precision, respectively. The assay was linear across the measurement range (0.0–100.00 μg/mL). No significant effect was seen with common interferents or commonly co-used drugs. Conclusions The ARK Levetiracetam Assay on Ortho Clinical Diagnostic Vitros 5600 can be used for routine determination of levetiracetam for conducting therapeutic drug monitoring and optimizing individual dosage regimen.

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“…The extensive literature survey revealed few methods are developed to estimate the drug Levetiracetam in raw material, tablets and in biological fluids using UV [5][6][7], RP-HPLC [2,[8][9][10][11][12][13][14][15][16][17][18], LC-MS [19][20][21], Capillary electrophoresis [22], UPLC [23,24], Gas Chromatography [25,26] and HPTLC [27]. However, there is no method developed yet for the simultaneous estimation of Levetiracetam and its preservatives by RP-HPLC in oral liquid dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Levetiracetam and its Preservatives In Oral Liquid Dosage form by Rp-Hplc Method

Grace¹,

Prabha²,

Jagadeeswaran³

et al. 2016

SOJMSE

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A rapid, simple, sensitive and accurate RP-HPLC method was developed and validated for simultaneous estimation of Levetiracetam and its preservatives (Methyl paraben and Propyl paraben) in oral liquid dosage form. The chromatographic separations were achieved on a Zorbax CN column (250×4.6 mm inner diameter, 5µm) using a mobile phase consisting of orthophosphoric acid buffer (pH 4.6)acetonitrile (75:25 v/v) at a flow rate of 1.0 mL/min with UV detection at 210nm. This system produced sharp peaks with good resolution, minimum tailing and satisfactory retention time for Levetiracetam, Methyl paraben and Propyl paraben were found to be 4.601, 9.905 and 19.291 respectively. The method was validated as per USP guidelines which include accuracy, precision, linearity and range, robustness specificity and ruggedness. The described method was linear over the range of 30-90 µg/ml for Levetiracetam with r² of 0.9999 and 60-180 µg/ml for Methyl paraben with r² 0.9997 and 20-60 µg/ml for Propyl paraben with r² 0.9999. The average recovery of the method was 98.2%, 99.3% and 98.7% for Levetiracetam, Methyl paraben and Propyl paraben respectively. The developed method is repeatable and selective for the analysis of Levetiracetam and its preservatives in oral liquid dosage form. Hence the method could be successfully applied for routine analysis. The developed method could also applicable in quality control testing in analysis of oral liquid dosage form and in process testing.

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Development and validation of a GC/MS method for the simultaneous determination of levetiracetam and lamotrigine in whole blood

Cited by 33 publications

References 24 publications

Determination of levetiracetam in human plasma by online heart‐cutting liquid chromatography: Application to therapeutic drug monitoring

Determination of levetiracetam in human plasma by online heart‐cutting liquid chromatography: Application to therapeutic drug monitoring

Validation of an Automated Assay for Levetiracetam (Keppra) on Vitros 5600

Simultaneous Estimation of Levetiracetam and its Preservatives In Oral Liquid Dosage form by Rp-Hplc Method

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