Validated high-performance liquid chromatographic method for the determination of lamotrigine in human plasma

Barbosa, Nádia R.; Mı́dio, Antônio Flávio

doi:10.1016/s0378-4347(00)00102-x

Cited by 44 publications

(23 citation statements)

References 23 publications

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“…The efficacy of lamotrigine as an add-on therapy has been well established in adults and children (Ben-Menachen, 2000) and was recently approved as monotherapy (Cheng et al, 2005). Although there are many studies describing the determination of lamotrigine in biological fluids (Cocciglio et al, 1991;Sallustio, Morris, 1997;Matar et al, 1998;Ashton et al, 1999;Botinger et al, 1999;Vidal et al, 1999;Angelis Stofordis et al, 1999;Barbosa, Midio, 2000;Torra et al, 2000;Croci et al, 2001;Castel-Branco et al, 2001;Patil, Bodhankar, 2005;Cheng et al, 2005;Kuldeep, Subash, 2005), and pharmaceutical formulation (Emani et al, 2006;Yousef, Taha, 2007) by several methods besides a dissolution test using HPLC method (Sripalakit et al, 2008), no dissolution test for this pharmaceutical solid dosage form has yet been described in any pharmacopoeia. Therefore, this paper describes the development and validation of a dissolution test for lamotrigine in tablets using a simple, fast and inexpensive ultraviolet method, and performs a comparative evaluation of the dissolution profiles of two different formulations.…”

Section: Introductionmentioning

confidence: 99%

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Martins

Paim

Steppe

2010

Braz. J. Pharm. Sci.

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A dissolution test for tablets containing 100 mg of lamotrigine was developed and validated. The dissolution test was applied to compare the dissolution profile of Neural ® with the reference product Lamictal ® . The analysis procedure was carried out using a simple ultraviolet method at 267 nm. After the determination of solubility and sink conditions, the parameters selected were paddles at 50 rpm, 900 mL of 0.01 M hydrochloric acid, and 30 minutes duration (single point). This method was validated for specificity, linearity, accuracy, precision and robustness. Lamotrigine stability was also evaluated in dissolution medium. Uniterms:Lamotrigine. Dissolution test/validation. Medicines/quality control.A finalidade deste estudo foi desenvolver e validar um método de dissolução para o fármaco lamotrigina na forma farmacêutica comprimido. Este método também foi utilizado para comparar o perfil de dissolução entre o Neural ® e o produto de referência Lamictal ® . O procedimento analítico foi realizado utilizando-se espectrofotometria de absorção no ultravioleta (267 nm) como forma de quantificação do fármaco. Após a determinação da solubilidade e das condições sink, os parâmetros selecionados foram: pás (50 rpm), 900 mL de ácido clorídrico 0.01 M e o tempo de 30 minutos (único ponto). Este método foi validado através da especificidade, linearidade, exatidão, precisão e robustez. A estabilidade da lamotrigina também foi avaliada no meio de dissolução.Unitermos: Lamotrigina. Teste de dissolução/validação. Medicamentos/controle de qualidade.

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Section: Introductionmentioning

confidence: 99%

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Martins

Paim

Steppe

2010

Braz. J. Pharm. Sci.

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“…The mobile phase consisted a mixture of buffer [KH 2 PO 4 (pH=7.0)]:acetonitrile:methanol (6:2:2), adjusted to pH 7.0 with TEA (triethyl amine). Flow rate was kept at 1.5 ml/min and wavelength determined was 307 nm (Barbosa and Mdio, 2000).…”

Section: High Performance Liquid Chromatographymentioning

confidence: 99%

Lamotrigine–dextran conjugates-synthesis, characterization, and biological evaluation

et al. 2010

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Synthesis of lamotrigine-dextran conjugates is done by oxidation of dextran using sodium periodate (NaIO 4 ), where the aldehyde groups formed were coupled with the amino (-NH 2 ) group of lamotrigine and reduced to secondary imine groups. Characterization of synthesized conjugates was done by using ultraviolet, infrared, nuclear magnetic resonance spectroscopy. Viscometer was used to determine molecular weight, and degree of substitution was estimated by complete hydrolysis of conjugates in borate buffer, which was found to be 8%. Buffer solutions with different pH, i.e., 1.2, 7.4, and 9.0 were used to perform the in vitro hydrolysis study and the amount of conjugates released was estimated by high performance liquid chromatography. The study showed that the rate of hydrolysis increases with increase in pH. The anticonvulsant and hepatotoxicity screening of the synthesized conjugates in different rat models showed that lamotrigine-dextran conjugates proved to be potentially safer than parent lamotrigine formulations.

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“…[2] A variety of analytical methods were reported earlier for the determination of lamotrigine in biological samples. These include radioimmunoassay, [3] high perfor-mance liquid chromatography (HPLC) methods with ultra-violet detection, [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] capillary electrophoresis, [22] gas chromatography-mass spectrometry (GC-MS), [23] electro-spray ionization-mass spectrometry (ESI-MS). [24,25] These conventional quantitative HPLC methods with classical ultra-violet or capillary electrophoresis detection provide insufficient sensitivity and longer chromatographic run time.…”

Section: Introduction Fig 1: Chemical Structure Of Lamotriginementioning

confidence: 99%

Development and Validation of Analytical Method for the Estimation of Lamotrigine in Human Plasma

Kumar¹

2017

WJPPS

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A Simple, rapid, selective and sensitive liquid chromatographic mass spectrometry method was developed and validated for the determination of Lamotrigine from human plasma. The drug was extracted by ethyl acetate. Lamotrigine was measured in plasma using a validated method with mass spectrometer detector. Chromatographic peaks were separated on 4μm Chromolith, RP C-18 (504.6mm, 4µ) using 80:20 v/v Phosphate buffer pH 2.5, Acetonitrile asmobile phase at a flow rate of 0.500 ml/min. The chromatograms showed good resolution and no interference from plasma. The mean recovery from human plasma was found to be above 85%. The method was linear over the concentration range of 5 μg/ml to 1200 μg/ml with coefficient of correlation (r2) 0.9987. Both intraday and interday accuracy and precision data showed good reproducibility. This method was successfully applied to pharmacokinetics studies.

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Validated high-performance liquid chromatographic method for the determination of lamotrigine in human plasma

Cited by 44 publications

References 23 publications

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Lamotrigine–dextran conjugates-synthesis, characterization, and biological evaluation

Development and Validation of Analytical Method for the Estimation of Lamotrigine in Human Plasma

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