Performance Characteristics of a New Levetiracetam Immunoassay and Method Comparison With a High-Performance Liquid Chromatography Method (original) (raw)
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A simple, sensitive and selective method for the determination of Levetiracetam by using rapid high-performance liquid chromatography/positive electroscopy ionization tandem mass spectroscopy was developed. The method consists of precipitation extraction with Acetonitrile followed by the analysis of the extracted sample by liquid chromatography-mass spectroscopy (LC-MS/MS) in selective reaction monitoring mode using electrospray ionization mode (ESI). Chromatography was performed on a C 18 reverse phase column, Methanol: Acetonitrile: 10mM ammonium acetate (45:45:10) as a mobile phase. The assay exhibited a linear dynamic range of 1 to 40µg/ml for Levetiracetam in human plasma. Stability assessment was also included. A run time of 3.0 min for each sample made it possible to analyse healthy volunteers participating in pharmacokinetics drug-drug interaction studies.
2020
Levetiracetam is a very effective antiepileptic which has been pointed out as a drug that should be monitored, despite its almost ideal pharmacokinetics. The objective was to adapt an HPLC-UV method to quantify levetiracetam in plasma based on previously published techniques, to provide an affordable analysis for routine use in a low-source setting. Pretreatment of plasma samples consisted of a deproteinization with acetonitrile. The analytical conditions implemented were a mobile phase of potassium dihydrogen phosphate buffer (10 mM, pH-4.6)/acetonitrile(93:7 v/v) at an isocratic flow rate of 0.5 mL/min, and UV detection at 192 nm. The retention time for levetiracetam was 7.45 min. Total runtime of the analysis was 9 min. The method was linear in the range of 5-60 μg/mL, repeatable and reproducible (CV<15%). Recovery was above 80%. The limit of detection was 0.19 μg/mL. The method was applied to determine levetiracetam concentration in plasma of 10 patients with epilepsy, and ph...
Microchemical Journal, 2021
Epilepsy is a brain disease characterized by abnormal electrical activity causing seizures or unusual behaviour, sensations and sometimes loss of awareness. Levetiracetam is among the new anticonvulsant drugs that are replacing drugs such as carbamazepine, phenytoin, phenobarbital and valproic acid. In this work, the GC/MS method for the determination of levetiracetam in the Forensic Toxicology Laboratory of the University of Santiago de Compostela has been compared with the immunoassay method used in the laboratory of the University Hospital of A Coruña. The determination was performed by GC/MS in SIM mode using Levetiracetam-D 6 as internal standard. The developed method was fully validated following the guidelines of the FDA. The method was shown to be linear in a concentration range of 2.5-25 µg/mL. Finally, the concentrations obtained by both methods were compared, obtaining a good correlation between the results.
Asian Journal of Pharmaceutical Research and Development, 2021
Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Levetiracetam bulk and tablet dosage form Methods: A spectrophotometric method and a HPLC method have been developed and validated for estimation of Levetiracetam in bulk. Method A (UV SPECTROMETRY Method): Methanol was used for the preparation of stock and working standard solutions of the drugs. 400-200nm UV range was used to scanned standard solutions of drugs using UV spectrophotometer. The λmax of Levetiracetam was found to be 220 nm. Method B (HPLC Method): The HPLC method for Levetiracetam was developed using cosmosil C18 (4.6 mm x 250 mm, particle size: 5 μm), as stationary particle, isocratic mode. Methanol: ACN: Water (60:20:20) pH3 as a mobile phase. The mobile phase was maintained at a flow rate of 1 ml / min and the detection was carried out at 220 nm. Both the methods were validated according to the ICH guidelines. Results: Levetiracetam was found to be linear in the concentration range of 10-50 µg/ml for spectrophotometric and HPLC method. Retention time was found to be 4.5 min for Levetiracetam. Interpretation and Conclusion: Results of validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Levetiracetam.
The present study depicts the development of a validated RP-HPLC method for the determination of the Levetiracetam in pharmaceutical tablet dosage form. RP-HPLC method was developed by utilizing Welchrom C18 Column (250 x 4.6 mm, 5µ), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10 mM Phosphate buffer: acetonitrile (50:50 v/v) (pH-3.0, adjusted with triethylamine). The flow rate was set to 1.0 ml/min with the responses measured at 243.2 nm using Shimadzu SPD-20A Prominence UV-Visible detector. The retention time of Levetiracetam was found to be 3.030 minutes. Linearity was established for Levetiracetam in the range of 10-50 µg/ml with correlation coefficient 0.9998. The LOD and the LOQ for Levetiracetam found to be 0.468 μg/ml and 1.421 μg/ml respectively. The amount of Levetiracetam present in the formulation was found to be 99.56 %. None of the excipients interfered with the analyte of interest. Considering all the results of validation parameters simplicity of the method and the cost effectiveness of the overall procedure, it is possible to conclude that the developed method can be suitable for the regular quality control determination of Levetiracetam in bulk as well as pharmaceutical dosage form.
Estimation of Levetiracetam in Tablet Dosage Form by RP-HPLC
A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of levetiracetam in tablet dosage form. A Sun Fire C18, 250 x 4.6 mm, 5 µm partical size, with mobile phase consisting of acetonitrile and 0.03 M potassium dihydrogen phosphate (pH adjusted to 3.0 with orthophosphoric acid) in the ratio of 15:85 v/v was used. The flow rate was 1 mL /min and the effluents were monitored at 210 nm. The retention time was 5.53 min. The detector response was linear in the concentration of 20-240 µg/mL. The respective linear regression equation being Y= 22119.684 x 6829.3428. The limit of detection and limit of quantification was 0.16 and 0.5 µg/mL respectively. The percentage assay of levetiracetam was 99.87%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of levetiracetam in bulk drug and in its pharmaceutical dosage form.
2013
A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Levetiracetam in bulk and tablets dosage forms. The separation was achieved on C 18 analytical column (250 mm × 4.6 mm i.d., 5.0 µm) using acetonitrile and distilled water in the ratio 80:20 v/v as mobile phase and at a flow rate of 1.0 mL/min. Detection was carried out using a UV detector at 210nm. The total chromatographic analysis time per sample was about 5.0min with Levetiracetam eluting at retention time of about 3.5min. The method is accurate (99.51% - 100.45%), and the standard curve was linear over the concentration range of 25-150µg/mL with R 2 close to one (0.999) and Y-intercept of 0.022. The limit of detection (LOD) and limit of Quantitation (LOQ) obtained for Levetiracetam were 0.01µg/mL and 0.09µg/mL, respectively. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of Levetira...
A Reviw on Analytical Methods-Levetiracetam
International Journal of Pharmaceutical Research and Applications, 2022
Levetiracetam is a pyrrolidonefamily antiepileptic drug of the second generation with a broad spectrum of activity. The US Food and Drug Administration authorized Levetiracetam as a broad-spectrum antiepileptic drug in 1999. The hydrophilic groups of Levetiracetam differentiate it from other earlier antiepileptic drugs. The following review covers the analytical techniques for the analysis of Levetiracetam.
Journal of Analytical Methods in Chemistry
Levetiracetam (LVT) is a widely used antiepileptic drug (AED). A less invasive sampling method for therapeutic drug monitoring (TDM) would be very useful particularly for children. Saliva has been shown as an adequate sample for TDM of some AEDs. Due to the high hydrophilicity of LVT its separation on common stationary phases is quite a challenge so that previous methods for determination of LVT in saliva employed either gradient high performance liquid chromatographic (HPLC) system or mass spectrometer as a detector. In this study the retention behavior of LVT on some common stationary phases was examined, with C8 being the most retentive. A simple isocratic HPLC method that is based on simple protein precipitation was developed and validated for the determination of LVT in saliva. The method was applied to a sample group of epileptic children for the purpose of assessing potential correlation with plasma LVT levels and to investigate patient’s compliance. The results confirmed a r...
Objective: To develop a validated stability indicating HPTLC method for determination of levetiracetam in pharmaceutical dosage form. Methods: Chromatographic separation was performed on aluminum plate precoated with Silica Gel 60 F254 using Toluene: Acetone: Methanol (6:2:2) v/v/) as mobile phase followed by densitometric scanning at 210 nm. Results: The chromatographic conditions gave compact spot for levetiracetam at Rf value of 0.35 ± 0.005 and specificity in accordance with international conference on harmonization (ICH) prescribed stress conditions. The calibration curve was found to be linear in the range 500-3000 ng/band. The limit of detection and quantitation were found to be 19.76 and 65.89 ng/band, respectively. Conclusion: A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of levetiracetam in pharmaceutical dosage form. The proposed method ca...