Development and validation of a LC/MS/MS method for simultaneous quantification of oxcarbazepine and its main metabolites in human serum

Paglia, Giuseppe; D’Apolito, Oceania; Garofalo, Daniela; Scarano, C.; Corso, Gaetano

doi:10.1016/j.jchromb.2007.10.025

Cited by 44 publications

(22 citation statements)

References 22 publications

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“…Multiple analytical methodologies have been reported for the measurement of 10-hydroxycarbazepine in plasma/serum including GC [129], GC/MS [130], HPLC [131,132], LC/MS [133], LC/MS/MS [134] and micellar electrokinetic chromatography [135]. TDM is justified when changes are expected that might alter 10-hydroxycarbazepine clearance including changes in renal function, pregnancy, and concomitant use of liver enzyme-inducing drugs.…”

Section: Oxcarbazepinementioning

confidence: 99%

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

Krasowski

2010

Pharmaceuticals

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In the past twenty years, 14 new antiepileptic drugs have been approved for use in the United States and/or Europe. These drugs are eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, rufinamide, stiripentol, tiagabine, topiramate, vigabatrin and zonisamide. In general, the clinical utility of therapeutic drug monitoring has not been established in clinical trials for these new anticonvulsants, and clear guidelines for drug monitoring have yet to be defined. The antiepileptic drugs with the strongest justifications for drug monitoring are lamotrigine, oxcarbazepine, stiripentol, and zonisamide. Stiripentol and tiagabine are strongly protein bound and are candidates for free drug monitoring. Therapeutic drug monitoring has lower utility for gabapentin, pregabalin, and vigabatrin. Measurement of salivary drug concentrations has potential utility for therapeutic drug monitoring of lamotrigine, levetiracetam, and topiramate. Therapeutic drug monitoring of the new antiepileptic drugs will be discussed in managing patients with epilepsy.

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Section: Oxcarbazepinementioning

confidence: 99%

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

Krasowski

2010

Pharmaceuticals

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“…Estimation of oxcarbazepine and its metabolites in biological fluids by high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) has been performed [5][6][7][8][9][10][11]. Only one method was reported for the determination of oxcarbazepine and its related compounds by reverse-phase liquid chromatography (RP-LC) [12], but the method deals with only three impurities present in active pharmaceutical ingredient, and forced degradation studies were not performed properly.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of oxcarbazepine in pharmaceutical formulation

Reddy¹,

Babu²,

Kumar³

2014

Acta Chromatographica

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Summary.A stability-indicating gradient reverse-phase liquid chromatographic method was developed for the quantitative determination of process-related impurities and forced degradation products of oxcarbazepine in pharmaceutical formulation. The method was developed by using Inertsil cyano (250 × 4.6 mm) 5 μm column with mobile phase containing a gradient mixture of solvent A (0.01 M sodium dihydrogen phosphate, pH adjusted to 2.7 with orthophosphoric acid and acetonitrile in the ratio of 80:20 v/v) and B (50:40:10 v/v/v mixture of acetonitrile, water, and methanol). The flow rate of mobile phase was 1.0 mL min −1 . Column temperature was maintained at 25°C and detection wavelength at 220 nm. Developed reverse-phase high-performance liquid chromatography (RP-HPLC) method can adequately separate and quantitate five impurities of oxcarbazepine, namely imp-A, imp-B, imp-C, imp-D, and imp-E. Oxcarbazepine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Oxcarbazepine was found to degrade significantly in acid, base, and oxidative stress conditions. The degradation products were well resolved from oxcarbazepine and its impurities. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

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“…Most of the analytical methods were published for the analysis of OXC in plasma samples by liquid chromatography-mass spectrometry (LC-MS) and high-performance liquid chromatography (HPLC) methods [6][7][8][9][10][11][12][13][14]. Very few HPLC and UV spectrophotometric methods were reported for the estimation of OXC in bulk and formulations [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC-PDA method development and validation for the estimation of oxcarbazepine in bulk and formulations

Raghavi¹,

Sindhura²,

Prashanthi³

et al. 2013

Acta Chromatographica

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Summary.A simple, precise, rapid, and accurate liquid chromatography-mass spectrometry (LC-MS) compatible reversed phase high-performance liquid chromatography-photodiode array detection (RP-HPLC-PDA) method has been developed and validated for the estimation of oxcarbazepine (OXC) in bulk and tablet formulations. The chromatographic separation was achieved on Phenomenex C 18 column (150 mm × 4.6 mm, 5.0 μm particle size) using the mobile phase comprising methanol-formic acid (0.02% v/v in water) in the ratio of 50:50 (v/v) at a flow rate of 1 mL min −1 , and OXC was eluted at 6.4 min. Quantification and linearity were achieved at 229 nm over the concentration range of 10-50 μg mL −1 , and the mean percentage of assay was found to be 100.03. The method was validated for specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), stability, and robustness as per the International Conference on Harmonisation (ICH) guidelines and it is suitable to be employed in quality control.

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Development and validation of a LC/MS/MS method for simultaneous quantification of oxcarbazepine and its main metabolites in human serum

Cited by 44 publications

References 22 publications

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

Development and validation of a stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of oxcarbazepine in pharmaceutical formulation

RP-HPLC-PDA method development and validation for the estimation of oxcarbazepine in bulk and formulations

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