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1 Introduction Oxcarbazepine (OXC) [ 1 ] is a carbamazepine keto analogue, Fig. 1 . OXC is antiepileptic drug that has been approved for treatment of partial seizures and trigeminal neuralgia in the United States and the European Union as well as

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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 C18 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.

Open access

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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A sensitive high-performance thin-layer chromatographic method has been developed for analysis of oxcarbazepine (OXC) in human plasma. This paper describes extraction of OXC from spiked human plasma by protein precipitation with acetonitrile and quantification using normal-phase HPTLC. The optimized mobile phase was ethyl acetate-toluene-methanol 7.0:2.0:1.0 ( v/v ). The detection was performed densitometrically at 254 nm by UV absorption. The detection limit of OXP is 2 ng and the limit of quantification is 10 ng ( n = 6). A good correlation coefficient ( r 2 = 0.99) was obtained for amounts of OXC in the range 10 to 3000 ng. Recovery was 75 to 80%. The internal standard used was chlorzoxazone, which was well resolved from OXC under the conditions specified. Analysis of OXP in human plasma was successfully performed without interference from endogenous materials.

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as ‘recommended’ for lamotrigine (LTG), oxcarbazepine (OXC) and its metabolite mono-hydroxy-derivative (MHD), and as ‘useful’ for gabapentin (GBP) and topiramate (TPM). Although the recommendation level of TDM for levetiracetam (LEV) decreased from

Open access

A quantitative densitometric high-performance thin-layer chromatographic (HPTLC) method has been established for analysis for two anti epileptic drugs, levetiracetam and oxcarbazepine in tablets. Separations on silica gel 60 F 254 HPTLC plates with toluene-acetone-methanol, 6:2:2 ( v/v ), as mobile phase enabled satisfactory resolution of the two drugs. This system afforded well resolved compact bands for levetiracetam and oxcarbazepine at R F 0.45 ± 0.02 and 0.55 ± 0.02, respectively. Densitometric scanning was performed in absorbance/reflectance mode at 200 and 261 nm. The method was successfully validated for precision, robustness, ruggedness, and recovery. The drugs were also subjected to photodegradation studies; oxcarbazepine was degraded in 9 h and levetiracetam was not degraded even after a long period. The method was found to be accurate and compatible with the conditions used.

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Acta Chromatographica
Authors:
Hao-ran Dai
,
Ya-hui Hu
,
Jia-yi Long
,
Ying Xia
,
Hong-li Guo
,
Jing Xu
,
Xuan-sheng Ding
,
Jing Chen
,
Xiao-peng Lu
, and
Feng Chen

, topiramate, phenytoin, primidone, pregabalin, lamotrigine, as well as 10-hydroxycarbazepine for 5.00 μg mL −1 ; phenobarbital, tiagabine, clonazepam, and oxcarbazepine for 1.00 μg mL −1 . 2.5.2 Linearity and limit of quantitation Linearity was accessed by

Open access

); mirtazapine, Orion Corporation (Espoo, Finland); olanzapine, Actavis Group PTC (Hafnarfjörður, Iceland); oxcarbazepine, Generics UK Ltd. (Potters Bar, Great Britain); perazine, HASCO-LEKS.A. (Wrocław, Poland); perphenazine, MSD (Warsaw, Poland); risperidone

Open access
Journal of Behavioral Addictions
Authors:
Marco D. T. Scanavino
,
Alia Garrudo Guirado
,
João Miguel Marques
,
Maria Luiza Sant'Ana do Amaral
,
Bruna Messina
,
Sirlene Caramello dos Reis
,
Vivian Boschesi Barros
,
Carmita Helena Najjar Abdo
,
Hermano Tavares
, and
Jeffrey T. Parsons

intervals. The medication protocol included SSRI (fluoxetine, paroxetine, or sertraline) delivered alone or combined with mood stabilizers (topiramate, divalproex sodium, oxcarbazepine, or lamotrigine) or mood stabilizers prescribed alone in the usual

Open access