A Simple Bioanalytical Method for the Quantification of Levetiracetam in Human Plasma and Saliva

Karaś, Katarzyna; Kuczyńska, Julita

doi:10.4172/2157-7064.1000310

Cited by 4 publications

(5 citation statements)

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“…For example, PPP procedure can result in signal suppression when LC/MS is used because of the presence of a precipitation agent, coprecipitation of interfering species, and lack of selectivity; SPE procedure gives interference, bad recovery with high standard deviation, is complicated, time consuming, and expensive; cartridges used for the extraction are relatively expensive with the risk of carryover and cross-contamination; and most of the chromatography techniques have tedious and time-consuming sample preparation procedures. [ 6 7 8 9 10 ]…”

Section: Discussionmentioning

confidence: 99%

“…[ 14 ] We developed our method for the serum estimation of levetiracetam modifying HPLC techniques mentioned in literature. [ 5 6 7 8 9 ] Liquid–liquid phase extraction method was used to prepare the samples prior to the running on the analytic HPLC-UV system. Theophylline was employed as the internal standard (IS) to control the extraction procedure.…”

Section: Methodsmentioning

confidence: 99%

“…Some of these procedures are complicated, time consuming, expensive, and lack selectivity. [ 6 7 8 9 10 ]…”

Section: Introductionmentioning

confidence: 99%

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Therapeutic drug monitoring of levetiracetam: Method validation using high-performance liquid chromatography-ultraviolet detector technique and usefulness in patient care setting

Munshi¹,

Vishwakarma²,

Gawde³

2022

Journal of Postgraduate Medicine

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Objectives: To develop and validate a modified HPLC-UV method for the estimation of serum levetiracetam levels and to assess the usefulness of serum levetiracetam estimation in epileptic patients. Materials and Methods: Modification of a previously existing HPLC-UV method was performed using liquid– liquid phase extraction and processing using reverse phase analytic HPLC-UV detector technique followed by method validation. Serum samples of patients attending our hospital's Therapeutic Drug Monitoring Outpatient Department services were analyzed for levetiracetam levels using the study method. Data of the past 6 years (2015–2020) were descriptively analyzed. Results: The modified HPLC-UV method was validated as per ICH Q2 (R1) 2005 guidelines. Usefulness of levetiracetam estimation was assessed in 1383 patients (635 children, 683 adults, 40 elderly, and 25 pregnant women). Levetiracetam levels were within the therapeutic range (TR) in 520 children, 543 young adults, 35 elderly patients, and nine pregnant women. In 112 of 232 patients with low levetiracetam levels, poor compliance was elicited. Of 641 patients on polytherapy, 446 patients had levetiracetam values within TR, whereas 29 had values above and 166 patients had values less than TR. Sodium valproate, phenytoin sodium, and carbamazepine affected levetiracetam levels when given concomitantly. Levetiracetam dose was adjusted in 61 patients with abnormal levels for better clinical response. Good seizure control was noted in 913 (82.47%) patients whose levels were within TR, whereas 136 (58.62%) patients with low levels reported an increase in seizure frequency. Conclusions: The modified HPLC-UV method is simple, rapid, efficient, and reliable for assaying serum levetiracetam.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Therapeutic drug monitoring of levetiracetam: Method validation using high-performance liquid chromatography-ultraviolet detector technique and usefulness in patient care setting

Munshi¹,

Vishwakarma²,

Gawde³

2022

Journal of Postgraduate Medicine

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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, [4][5][6] RP-HPLC, [7][8][9][10][11][12][13][14][15][16][17] LC-MS, [18][19][20] Capillary electrophoresis, 21 UPLC, 22,23 Gas Chromatography 24,25 and HPTLC. 26 However, there is no stability indicating method developed yet for the estimation of Levetiracetam and its impurities by RP-HPLC in liquid dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Stability Indicating RP-HPLC Method for Quantitative Estimation of Levetiracetam and its Impurities in Pharmaceutical Dosage Form

Rao

Anuradha

Ramachandran

et al. 2023

Int J. Pharm. Investigation

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Objectives: A simple, precise, accurate, robust and selective stability-indicating reverse phase high performance liquid chromatographic method for the separation and quantification of Levetiracetam and its impurities in Levetiracetam liquid dosage formulations. Materials and Methods: The analysis of improved RP-HPLC method for the separation and quantification of Levetiracetam and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Inertsil ODS-3V, 150 x 4.6 mm, 3µm and the mobile phase consists of two channels A and B. Channel-A: pH 5.50 phosphate buffer : acetonitrile (950:50 v/v) and channel-B: acetonitrile: water (90:10 v/v). The flow rate is 1.0 ml/min. The column temperature was maintained at 40°C and sample temperature was maintained at 25°C, injection volume 10µL and wavelength fixed at 205 nm. Results: For selectivity, the chromatograms were recorded for standard and sample solutions of Levetiracetam and its related substances. Selectivity studies reveal that the peak is well separated from each other. Therefore the method is selective for the determination of related substances in Levetiracetam. There is no interference of diluent and placebo at Levetiracetam and impurities peaks. The elution order and the retention times of impurities and Levetiracetam obtained from individual standard preparations and mixed standard preparations are comparable. The limit of detection (LOD) and limit of quantitation (LOQ) for Levetiracetam standard 0.0023% and 0.0070%, impurity-A 0.0049% and 0.0147%, impurity-C 0.0024% and 0.0074% and Levetiracetam RC-A 0.0091% and 0.0277% respectively. The linearity results for Levetiracetam and all the impurities in the specified concentration range are found satisfactory, with a correlation coefficient greater than 0.99.Calibration curve was plotted and correlation co-efficient for Levetiracetam and its impurities found to be 1.000, 0.9999, 1.000 and 0.9994 respectively. The accuracy studies were shown as %recovery for Levetiracetam and its impurities at specification level. The limit of % recovered shown is in the range of 80 and 120% and the results obtained were found to be within the limits. Hence the method was found to be accurate. For precision studies six replicate injections were performed. %RSD was determined from the peak areas of Levetiracetam and its impurities. The acceptance limit should be not more than 10, and the results were found to be within the acceptance limits. Conclusion: The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

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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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A Simple Bioanalytical Method for the Quantification of Levetiracetam in Human Plasma and Saliva

Cited by 4 publications

References 0 publications

Therapeutic drug monitoring of levetiracetam: Method validation using high-performance liquid chromatography-ultraviolet detector technique and usefulness in patient care setting

Therapeutic drug monitoring of levetiracetam: Method validation using high-performance liquid chromatography-ultraviolet detector technique and usefulness in patient care setting

Stability Indicating RP-HPLC Method for Quantitative Estimation of Levetiracetam and its Impurities in Pharmaceutical Dosage Form

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

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