Simple GC–MS method for analysis of Levetiracetam and process-related toxic impurity

Ali, Hazim M.; Mahmoud, Mohamed; Abdelwahab, Nada S.

doi:10.1016/j.microc.2019.02.063

Cited by 8 publications

(2 citation statements)

References 14 publications

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“…Coupling MS with LC and GC greatly improves the selectivity and sensitivity of chromatographic methods [4,5]. Numerous methods have been recorded for estimating CAB, alone or in combination with other drugs, which includes spectrophotometry [6][7][8], HPLC [8][9][10][11][12], TLC [10], voltammetry [13][14][15][16], and LC/MS/ MS [17,18].…”

Section: Introductionmentioning

confidence: 99%

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

et al. 2022

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Cabergoline (CAB) is effective prolactin lowering drug. Evaluation of the bioequivalence for the new test product (0.5 mg CAB film-coated tablets) in Egypt is strongly needed for approval of the drug by the official health authority. Therefore, a highly sensitive and rapid (LC–MS/MS) method was validated for CAB analysis in human plasma. CAB was extracted from plasma via diethyl ether using Quetiapine (QUE) as an internal standard. Multiple reaction monitoring (MRM) in positive ion mode was used, m/z 452.3 → 381.2 for CAB and 384.2 → 253.1 for QUE. Separation was accomplished on a reversed-phase C18. FDA procedures for the bio-analytical method were followed. The method was used in the bioequivalence study to compare the test product (0.5 mg CAB) versus Dostinex tablets, on 24 healthy Egyptian volunteers. The total analysis time was 5.5 min for each sample which permits analysis of various samples per day. The linearity range was from 2.00 to 200.00 pg/mL for CAB. LOD and LOQ were found to be 0.5 and 1.6 pg/mL, respectively. The final greenness numerical value was 0.63 using AGREE tool. The results of pharmacokinetic parameter Tmax were 2.17, and 2.33 h; for test and reference products, respectively. The generic formulation of test product is considered bioequivalent to the reference product Dostinex 0.5 mg tablets and satisfies the requirements of the Egyptian market. The merits of the method over the previous published methods are low cost; availability of cheap internal standard; rapidness; use of acetonitrile-free solvents mobile phase.

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Section: Introductionmentioning

confidence: 99%

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

et al. 2022

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“…Some of these approaches include spectrophotometric method, 11 gas chromatography mass spectrometry (GC-MS), [12][13][14] HPLC, [15][16][17] HPLC-UV, [18][19][20] ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), 21 capillary electrophoresis, 22 liquid chromatography mass spectrometry (LC-MS), 23,24 and electrochemical method. 25 To the best of our knowledge, only two MIP based technique has been recognized for the investigation of LEV.…”

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confidence: 99%

Electrochemical Sensor for Levetiracetam Therapeutic Monitoring in Biological Fluid Utilizing Molecular Imprinted Polymer Electrografted onto Pencil Graphite Electrode

El Shazely,

Mahmoud,

Saad

et al. 2024

J. Electrochem. Soc.

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A newly-developed, molecularly imprinted copolymer (MIP) has been constructed and effectively employed as a highly-selective recognition element for anti-epileptic drug; levetiracetam (LEV) in low concentrations. The MIP sensor for LEV was fabricated via in-situ electrochemical co-polymerization of o-phenylenediamine (o-PD) and L-dopa as functional monomers in the presence of LEV as a template molecule onto pencil graphite electrode. UV-Spectrophotometric technique was carried out to inspect and assess the template-monomer binding interactions. The molecularly imprinted copolymer's structure and morphology were examined through X-ray photoelectron spectroscopy and scanning electron microscopy. Multiple experimental parameters have been investigated and optimized in order to improve the sensor's responsiveness towards LEV. Utilizing differential pulse voltammetry, quantitative measurements of MIP-based LEV detection were achieved indirectly by measuring the decrease in response of redox probe upon binding of LEV to the 3D cavities of MIP in phosphate buffer saline pH 7.40. The method's validation was performed in accordance with ICH guidelines. The fabricated sensor showed a linear voltammetric response with a linearity range of (1.5 x10-12 – 1.0 x10-10 M). The sensor was able to effectively detect LEV in spiked artificial human saliva.

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Trace level determination of eleven nervous system–active pharmaceutical ingredients by switchable solvent-based liquid-phase microextraction and gas chromatography–mass spectrometry with matrix matching calibration strategy

Bozyiğit

Ayyıldız

Chormey

et al. 2022

Environ Monit Assess

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Simple GC–MS method for analysis of Levetiracetam and process-related toxic impurity

Cited by 8 publications

References 14 publications

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

A validated LC–MS/MS method for analysis of Cabergoline in human plasma with its implementation in a bioequivalent study: investigation of method greenness

Electrochemical Sensor for Levetiracetam Therapeutic Monitoring in Biological Fluid Utilizing Molecular Imprinted Polymer Electrografted onto Pencil Graphite Electrode

Trace level determination of eleven nervous system–active pharmaceutical ingredients by switchable solvent-based liquid-phase microextraction and gas chromatography–mass spectrometry with matrix matching calibration strategy

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