A validated chiral LC method for the enantioselective analysis of Levetiracetam and its enantiomer R-α-ethyl-2-oxo-pyrrolidine acetamide on amylose-based stationary phase

Rao, B.M.; Ravi, R.; Reddy, B. Shyam Sundar; Sivakumar, S.; Chand, I. Gopi; Kumar, K. Praveen; Acharyulu, Palle V. R.; Reddy, G. Om; Srinivasu, M.K.

doi:10.1016/j.jpba.2004.03.015

Cited by 27 publications

(13 citation statements)

References 8 publications

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“…The proposed method was found to be superior to the reported methods with respect to speed, simplicity, sensitivity and cost-effectiveness. It is less costly and it does not require expensive equipment or high-cost reagents like the reported HPLC methods (2,6,8,9,11 …”

Section: Analysis Of Pharmaceutical Productsmentioning

confidence: 99%

Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations

Hadad¹,

Salam²,

Emara³

2011

Acta Pharmaceutica

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Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulationsApplication of a sensitive and rapid flow injection analysis (FIA) method for determination of topiramate, piracetam, and levetiracetam in pharmaceutical formulations has been investigated. The method is based on the reaction withortho-phtalaldehyde and 2-mercaptoethanol in a basic buffer and measurement of absorbance at 295 nm under flow conditions. Variables affecting the determination such as sample injection volume, pH, ionic strength, reagent concentrations, flow rate of reagent and other FIA parameters were optimized to produce the most sensitive and reproducible results using a quarter-fraction factorial design, for five factors at two levels. Also, the method has been optimized and fully validated in terms of linearity and range, limit of detection and quantitation, precision, selectivity and accuracy. The method was successfully applied to the analysis of pharmaceutical preparations.

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Section: Analysis Of Pharmaceutical Productsmentioning

confidence: 99%

Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations

Hadad¹,

Salam²,

Emara³

2011

Acta Pharmaceutica

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“…All compounds are eluted within 7 min, which can be considered as an advantage. Thus, the analyses are finished quite fast compared with the LC method [9] where the analysis time was 13.9 min. The detection-and quantification limits were determined by injecting consecutively solutions containing 0.5, 0.05, 0.025, 0.01, and 0.0025 mg/mL of both the enantiomers.…”

Section: Elution Order Detection Limit (Lod) and Quantification Limmentioning

confidence: 99%

“…Different dissolution procedures have been tested. First, a literature-based procedure [9] was tested, using isopropanol to dissolve levetiracetam from its matrix. However, this solvent caused broad peaks of the internal standard during analysis, and was therefore replaced by water, as levetiracetam is readily soluble in this solvent.…”

Section: Application To Keppra Tabletsmentioning

confidence: 99%

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Enantiomeric impurity determination of levetiracetam using capillary electrochromatography

Mangelings

Saevels²,

Heyden³

2006

J. Sep. Sci.

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CEC was used to develop a method for the enantiomeric excess determination of levetiracetam, an antiepileptic drug. Different types of calibration curve were evaluated for use in the range between 0.01 and 1 mg/mL when aniracetam was used as an internal standard. The method gave comparable results when only the areas of the impurity were used in the calibration curve. The predicted detection and quantification limits from the S/N were 1.1 and 3.6 microg/mL, respectively. However, experimental results showed that LOD and LOQ were underestimated. Repeatability of injection was demonstrated by the RSD values obtained for retention time, resolution, ratios of the areas impurity/internal standard, and areas of impurity and internal standard individually, which were below or equal to 9.30%. The between-days variability experiments indicated that it is better to make a calibration curve daily. The finally selected calibration curves were used to test the accuracy of the developed method on bulk samples and Keppra tablets containing 250 mg levetiracetam. Both selected calibration curves performed similarly. The one using the internal standard information gave overall recoveries between 88 and 118%, while the one using areas gave results between 84 and 118%.

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“…Several chromatographic methods have been published for quantification of LEV concentrations in biological fluids such as saliva and plasma (or serum) for TDM and in urine for pharmacokinetic aims. They include different subtypes of liquid chromatography with various detection systems (Contin et al, 2008;Grim et al, 2003;Guo et al, 2007;Jain et al, 2006;Juenke et al, 2006;Kuhn, Knabbe, 2013;Lancelin et al, 2007;Martens-Lobenhoffer, BodeBoger, 2005;Matar, 2008;Pucci et al, 2004;Rao et al, 2004;Ratnaraj, Doheny, Patsalos, 1996;Shibata et al, 2012), gas chromatography (Isoherranen et al, 2000;Mecarelli et al, 2007) and microemulsion electrokinetic chromatography (Ivanova et al, 2003). An analytical nonchromatographic method, capillary electrophoresis, is also described (Shihabi, Oles, Hinsdale, 2003).…”

Section: Introductionmentioning

confidence: 99%

Stir bar-sorptive extraction, solid phase extraction and liquid-liquid extraction for levetiracetam determination in human plasma: comparing recovery rates

Freitas‐Lima

Ferreira

Bertucci

et al. 2015

Braz. J. Pharm. Sci.

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Levetiracetam (LEV), an antiepileptic drug (AED) with favorable pharmacokinetic profile, is increasingly being used in clinical practice, although information on its metabolism and disposition are still being generated. Therefore a simple, robust and fast liquid-liquid extraction (LLE) followed by highperformance liquid chromatography method is described that could be used for both pharmacokinetic and therapeutic drug monitoring (TDM) purposes. Moreover, recovery rates of LEV in plasma were compared among LLE, stir bar-sorptive extraction (SBSE), and solid-phase extraction (SPE). Solvent extraction with dichloromethane yielded a plasma residue free from usual interferences such as commonly co-prescribed AEDs, and recoveries around 90% (LLE), 60% (SPE) and 10% (SBSE). Separation was obtained using reverse phase Select B column with ultraviolet detection (235 nm . The intra-and inter-assay precision and accuracy were studied at three concentrations; relative standard deviation was less than 10%. The limit of quantification was 2.8 µg mL -1 . This robust method was successfully applied to analyze plasma samples from patients with epilepsy and therefore might be used for pharmacokinetic and TDM purposes.Uniterms: Levetiracetam/pharmacokinetic. High performance liquid chromatography. Antiepileptic drugs/therapeutic monitoring. Epilepsy/treatment.Levetiracetam, fármaco antiepiléptico com perfil farmacocinético favorável, tem sido cada vez mais utilizado na prática clínica, embora informações sobre seu metabolismo e disposição cinética ainda estejam sendo geradas. Um método simples, robusto e rápido de extração líquido-líquido seguido por análise por cromatografia líquida de alta eficiência é aqui descrito para servir tanto a investigações farmacocinéticas quanto à monitorização terapêutica. Além disso, as taxas de recuperação do levetiracetam em plasma foram comparadas entre a extração líquido-líquido, a extração sortiva em barra de agitação e a extração em fase sólida. Extração com o solvente diclorometano resultou em plasma livre de interferentes, tais como fármacos antiepilépticos co-prescritos, e apresentou taxas de recuperação em torno de 90% (extração líquido-líquido), 60% (extração em fase sólida) e 10% (extração sortiva em barra de agitação). A separação foi obtida utilizando-se coluna de fase reversa Select B e detecção ultravioleta (235 nm). A fase móvel foi composta por metanol:tampão acetato de sódio 0,125 M pH 4,4 (20:80, v/v). O método mostrou-se linear para o intervalo de 2,8 a 220,0 µg mL -1. Precisão intra-e interdias e a exatidão foram avaliadas em três concentrações; o desvio padrão relativo foi inferior a 10%. O limite de quantificação foi 2.8 µg mL . Este método foi aplicado para análise de amostras de plasma de pacientes com epilepsia e, desta forma, pode ser utilizado satisfatoriamente tanto para fins de farmacocinética quanto de monitorização terapêutica.Unitermos: Levetiracetam/farmacocinética. Cromatografia líquida de alta eficiência. Antiepiléticos/ monitorização terapêutica. Epilepsia/trata...

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A validated chiral LC method for the enantioselective analysis of Levetiracetam and its enantiomer R-α-ethyl-2-oxo-pyrrolidine acetamide on amylose-based stationary phase

Cited by 27 publications

References 8 publications

Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations

Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations

Enantiomeric impurity determination of levetiracetam using capillary electrochromatography

Stir bar-sorptive extraction, solid phase extraction and liquid-liquid extraction for levetiracetam determination in human plasma: comparing recovery rates

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