Desenvolvimento de método analítico para quantificação do efavirenz por espectrofotometria no UV-Vis

Alves, Lariza Darlene Santos; Rolim, Larissa Araújo; Fontes, Danilo Augusto Ferreira; Rolim-Neto, Pedro José; Soares, Mônica Felts de La Roca; Sobrinho, José Lamartine Soares

doi:10.1590/s0100-40422010000900026

Cited by 15 publications

(10 citation statements)

References 17 publications

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“…It is important to consider that the solution containing a compound with low solubility and high molar absorptivity may be diluted, as solution containing a compound with high solubility and low molar absorptivity may not be necessarily diluted. Thus, the dilution mainly depends on molar absorptivity of the drugs (Alves et al, 2010;Filippin, Souza, 2006;Pereira et al, 2011;Ruela, Araújo, Pereira, 2009). The cumulative quantity of dissolved drug was corrected for each sample interval according to volume collected from the each vessel.…”

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confidence: 99%

Equilibrium solubility versus intrinsic dissolution: characterization of lamivudine, stavudine and zidovudine for BCS classification

Dezani

Pereira

Caffaro

et al. 2013

Braz. J. Pharm. Sci.

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Solubility and dissolution rate of drugs are of major importance in pre-formulation studies of pharmaceutical dosage forms. The solubility improvement allows the drugs to be potential biowaiver candidates and may be a good way to develop more dose-efficient formulations. Solubility behaviour of lamivudine, stavudine and zidovudine in individual solvents (under pH range of 1.2 to 7.5) was studied by equilibrium solubility and intrinsic dissolution methods. In solubility study by equilibrium method (shake-flask technique), known amounts of drug were added in each media until to reach saturation and the mixture was subjected to agitation of 150 rpm for 72 hours at 37 °C. In intrinsic dissolution test, known amount of each drug was compressed in the matrix of Wood's apparatus and subjected to dissolution in each media with agitation of 50 rpm at 37 °C. In solubility by equilibrium method, lamivudine and zidovudine can be considered as highly soluble drugs. Although stavudine present high solubility in pH 4.5, 6.8, 7.5 and water, the solubility determination in pH 1.2 was not possible due stability problems. Regarding to intrinsic dissolution, lamivudine and stavudine present high speed of dissolution. Considering a boundary value presented by Yu and colleagues (2004), all drugs studied present high solubility characteristics in intrinsic dissolution method. Based on the obtained results, intrinsic dissolution seems to be superior for solubility studies as an alternative method for biopharmaceutical classification purposes.Uniterms: Drugs/solubility. Drugs/dissolution rate. Intrinsic dissolution/method/biopharmaceutical classification. Biopharmaceutical Classification System.A solubilidade e a taxa de dissolução de fármacos são de grande importância em estudos de pré-formulação de formas farmacêuticas. A melhora na solubilidade permite que os fármacos sejam candidatos potenciais à bioisenção, podendo ser uma boa maneira para desenvolver formulações dose-eficientes. O comportamento de solubilidade da lamivudina, estavudina e zidovudina em solventes individuais (sob faixa de pH 1,2 a 7,5) foi estudado pelos métodos de solubilidade em equilíbrio e dissolução intrínseca. No estudo de solubilidade pelo método do equilíbrio (método de agitação de frascos), conhecidas quantidades do fármaco foram adicionadas em cada meio até atingirem a saturação e a mistura foi submetida à agitação de 150 rpm por 72 horas a 37 °C. No ensaio de dissolução intrínseca, conhecida quantidade de cada fármaco foi comprimida na matriz do aparato de Wood e submetida à dissolução em cada meio com agitação de 50 rpm a 37 °C. No método de solubilidade em equilíbrio, a lamivudina e a zidovudina podem ser consideradas como fármacos altamente solúveis. Embora a estavudina apresente alta solubilidade nos meios pH 4,5, 6,8, 7,5 e água, a determinação da solubilidade em pH 1,2 não foi possível devido a problemas de estabilidade. Com relação à dissolução intrínseca, a lamivudina e a estavudina apresentaram alta velocidade de dissolução. Considerando o valor ...

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mentioning

confidence: 99%

Equilibrium solubility versus intrinsic dissolution: characterization of lamivudine, stavudine and zidovudine for BCS classification

Dezani

Pereira

Caffaro

et al. 2013

Braz. J. Pharm. Sci.

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“…Its main limitation is its low selectivity 19 . When working with complex materials such as guarana, which has several active compounds, the lack of selectivity of UV spectroscopy makes it difficult to distinguish these compounds 2 .…”

Section: Fig 1: Chemical Structure Of (A) Caffeine (Caf) and (B) Catmentioning

confidence: 99%

Untitled

2016

IJPSR

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ABSTRACT:A method using derivative UV spectrophotometry was developed and validated for the determination of methylxanthines and tannins in guarana bulk, using caffeine and catechin as markers. The spectra were obtained using first order derivatization, Δλ=20.000, and scale factor of 10. The quantification of actives was performed using wavelengths of 244 and 277 nm for catechin and caffeine, respectively. The parameters of specificity, linearity, precision, accuracy, robustness, limits of detection (LOD) and quantification (LOQ) were established to validate the method. The method was shown to be specific for quantification of methylxanthines and tannins, and linear over the concentration range 5-35 µg mL -1 , with a correlation coefficient of r=1(caffeine) and r=0.9993 (catechin). The results indicated good intra-day and inter-day precision with RSDs less than 2%. The method was accurate, exhibiting recoveries between 98 and 102%. The LODs were 0.184 µg mL -1 (caffeine) and 0.368 µg mL -1 (catechin), and the LOQs were 0.552 µg mL -1 (caffeine) and 1.104 µg mL -1 (catechin). Methylxanthines and tannins were quantified, and contents of 10 µg mL -1 and 20 µg mL -1 , respectively, were observed.

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“…An example with these characteristics is a technique of absorption spectrophotometry in the ultraviolet-visible region (UV-Vis) a simple, fast and inexpensive technique, widely used in quality control laboratories and easy of handling (Komarova et al, 2009;Alves et al, 2010;Spagnol, Oliveira, Isaac, Corrêa, & Salgado, 2015).…”

Section: Introductionmentioning

confidence: 99%

<b>Development and validation of analytical methodology for quantification of propranolol hydrochloride in a multiparticulate biphasic system by UV-vis spectrophotometry

Martins¹,

Rosa

Souza³

et al. 2018

Acta Sci. Technol.

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ABSTRACT. Hypertension is one of the most important mortality risks in the world and is considered the leading cause of deaths associated with cardiovascular disease. In an attempt to improve the treatments and apply them to a large number of disorders, a propranolol hydrochloride (Prop) based medicine it was developed in our laboratory, employing a multiparticulate system which operates in a biphasic manner, one portion of immediate and other of modified release. This study aimed at developing and validating a suitable method to quantify this new version of the drug using UV spectrophotometry, following what is recommended in RE 899/2003. The results showed that the method employed was linear, accurate, precise and robust in the range of 0.8 to 96.0 μg mL -1 , which allows it for routine use in quality control laboratories.Keywords: biphasic release, multiparticulate system, pellets.Desenvolvimento e validação de metodologia analítica para quantificação de cloridrato de propranolol em sistema multiparticulado bifásico por espectrofotometria ultravioleta RESUMO. A hipertensão é um dos mais importantes riscos de mortalidade no mundo, sendo considerada a principal causa de mortes associadas a doenças cardiovasculares. Em uma tentativa de obter tratamentos mais eficazes e aplicados a um grande número de desordens, foi desenvolvido, em nosso laboratório, um medicamento à base de cloridrato de propanolol (Prop), empregando um sistema multiparticulado que agisse de forma bifásica, sendo uma fração de liberação imedita e outra de liberação prolongada. Este trabalho teve como objetivo desenvolver e validar um método direcionado para a quantificação dessa nova versão do medicamento, empregando espectrofotometria UV e seguindo o recomendado na RE 899/2003. O método proposto foi linear, exato, preciso e robusto na faixa de 0,8 a 96 μg mL -1 , o que permite sua utilização na rotina de um laboratório de controle de qualidade.Palavras-chave: liberação bifásica, sistema multiparticulado, péletes.

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Desenvolvimento de método analítico para quantificação do efavirenz por espectrofotometria no UV-Vis

Cited by 15 publications

References 17 publications

Equilibrium solubility versus intrinsic dissolution: characterization of lamivudine, stavudine and zidovudine for BCS classification

Equilibrium solubility versus intrinsic dissolution: characterization of lamivudine, stavudine and zidovudine for BCS classification

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<b>Development and validation of analytical methodology for quantification of propranolol hydrochloride in a multiparticulate biphasic system by UV-vis spectrophotometry

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