LC method for the determination of oxcarbazepine in pharmaceutical preparations

Qi, Meiling; Wang, P.; Wang, L.J.; Fu, Ruonong

doi:10.1016/s0731-7085(02)00602-7

Cited by 19 publications

(10 citation statements)

References 9 publications

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“…In the literature survey, there were very few LC assay methods that have been reported for determination of oxcarbazepine in pharmaceutical preparation [3,4]. 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].…”

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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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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“…Very few HPLC and UV spectrophotometric methods were reported for the estimation of OXC in bulk and formulations [15][16][17]. There were also methods that described forced degradation studies that were reported with the mobile phases containing phosphate salt buffers [18,19] and are not compatible with LC-MS detection.…”

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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“…Several high-performance liquid chromatographic (HPLC) methods have been reported in the literature for the determination of OXC (Pathare et al, 2007;Qi et al, 2003). To the best of our knowledge, one spectrophotometric method has been reported for the analysis of this drug in the literature, based on the reduction of ferric ions in their salt form to ferrous ions by the drug (Ramaa et al, 2006). The HPLC method is widely employed in quality control assessment of drugs because of its sensitivity, repeatability and specificity.…”

Section: Introductionmentioning

confidence: 99%

Oxcarbazepine: validation and application of an analytical method

Enéas

Oliveira

Pianetti

2010

Braz. J. Pharm. Sci.

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Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of content and the amount of drug dissolved during the first hour.Uniterms: Oxcarbazepine/quantitative analysis. Anticonvulsants/quantitative analysis. UV spectrophotometric/method validation. Capsules/dissolution. Oxcarbazepina (OXC) é um fármaco anticonvulsivante e estabilizante do humor. O desenvolvimento e validação de método analítico para quantificação da OXC são de fundamental importância devido à ausência de monografias farmacopéicas oficiais para esse fármaco. Nesse trabalho, um método espectrofotométrico UV para determinação da OXC foi desenvolvido. O método proposto foi validado seguindo os parâmetros de linearidade, precisão, exatidão e especificidade de acordo com as normas da Conferência Internacional de Harmonização. Cápsulas de OXC 150 mg foram preparadas e analisadas utilizando-se o método analítico validado. As formulações foram avaliadas com relação à compatibilidade fármaco-excipientes, fluidez, determinação de peso, tempo de desintegração, doseamento, uniformidade de conteúdo e quantidade do fármaco dissolvido após 60 minutos.Unitermos: Oxcarbazepina/análise quantitativa. Anticonvulsivante/análise quantitativa. Espectrofotometria UV/validação do método. Cápsulas manipuladas/dissolução.

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LC method for the determination of oxcarbazepine in pharmaceutical preparations

Cited by 19 publications

References 9 publications

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

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

Oxcarbazepine: validation and application of an analytical method

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