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Search Results: 1 - 10 of 164814 matches for " Hérida Regina Nunes Salgado "
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Development and Validation of an LC-MS/MS Method for Quantitative Analysis of Mirtazapine in Human Plasma  [PDF]
Marlus Chorilli, Rudy Bonfilio, Caroline Rossim Louvandini, Francine Andressa Rosa Madia Gon?alves, Hérida Regina Nunes Salgado
American Journal of Analytical Chemistry (AJAC) , 2011, DOI: 10.4236/ajac.2011.26074
Abstract: Mirtazapine (MTZ) is an antidepressant drug, which belongs to the chemical class of piperazinoazepines. A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the quantifica- tion of MTZ in plasma at the concentrations associated with therapy. Diazepam (DZP) was used as internal standard, added to 200 μL of plasma sample prior to a liquid-liquid extraction using hexane. Chroma- tographic separation was achieved on an Agilent® Eclipse XDB C-18 column (100 × 2.1 mm, 3.5 μm) in iso- cratic mode at 40?C. Mobile phase was 10 mM ammonium acetate/acetonitrile/formic acid (60/40/0.1, v/v/v) at a constant flow rate of 0.5 mL?min–1. The injection volume was 10 ?L and the total run time was 3.2 min. The method shows selectivity and linearity. The detection and quantitation limits were established at 0.17 and 0.50 ng?mL–1, respectively. The extraction recoveries for MTZ and DZP were found to be between 84.9 and 93.9%. The intra-day and inter-day precision and accuracy fulfill at the international acceptance criteria. The method shows to be stable for the studied parameters. Therefore, a rapid, specific, and sensitive LC-MS/MS method for quantification of MTZ in human plasma was developed and can be used in therapeu- tic drug monitoring of this drug.
Validation of a HPLC Method for Determination of Glutamine in Food Additives Using Post-Column Derivatization  [PDF]
Marlus Chorilli, Hérida Regina Nunes Salgado, Fabiana De Santana Santos, Lucélia Magalh?es Da Silva
American Journal of Analytical Chemistry (AJAC) , 2012, DOI: 10.4236/ajac.2012.32016
Abstract: An ion-exchange chromatography (IEC) followed by post-column derivatization method was validated for the determination of glutamine in food additive products. The chromatographic method was carried out on a sodium cation-exchange column and using detection at 570 nm. The mobile phase consisted of sodium eluant, pH 3.15, with 5% sulfolane, sodium eluant, pH 7.40 and sodium column regenerant. The method was linear in the range of 4 - 50 μg/mL (r2 = 0.9999). The accuracy was 99.78%. Moreover, method validation demonstrated acceptable results for precision and robustness. The method was found to be able to use for routine analysis of the glutamine.
Development and Validation of Dissolution Test for Fluconazole Capsules by HPLC and Derivative UV Spectrophotometry
Josilene Chaves Ruela Corrêa,Cristina Duarte Vianna-Soares,Hérida Regina Nunes Salgado
Chromatography Research International , 2012, DOI: 10.1155/2012/610427
Abstract: The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900?mL of HCl 0.1?M, 37 ± 0.5?°C using baskets with 50?rpm for 30?min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed. 1. Introduction The dissolution can be defined in a narrow sense as the process by which a solid substance is incorporated into the solvent to form a solution. However, in a broad sense, it is more than a simple measurement of solubility rate and can be better described as physical test to predict the drug release from a dosage form, for a given area for some precise time. Fundamentally, this process is controlled by the affinity between the solvent and the solid substance and the way by which the pharmaceutical system releases the drug [1, 2]. According to Mehta and coworkers [3] dissolution test provides an indication of bioavailability of a drug and, thus, pharmaceutical equivalence from batch to batch. The dissolution test is an important tool in quality control of drugs and it becomes more important for drugs with relatively low water solubility, including broad spectrum antifungal fluconazole. Some characteristics of this drug are not well defined, for instance, its classification as high or low soluble in water or its classification in the biopharmaceutical classification system [4–6]. Well-defined drug features, together with the dissolution studies, can be an important tool to justify the use of in vitro methods instead of in vivo methods when they are requested. The aim of this dissolution study is to contribute to define fluconazole dissolution conditions, what can be the focus for further studies. A dissolution method should be discriminatory, and it
Stability study of azithromycin in ophthalmic preparations
Moreno, Andréia de Haro;Silva, Maria Fernanda Conz da;Salgado, Hérida Regina Nunes;
Brazilian Journal of Pharmaceutical Sciences , 2009, DOI: 10.1590/S1984-82502009000200005
Abstract: a stability study of azithromycin in ophthalmic preparations was developed by submission to different types of light, temperature and ph, using the biodiffusion assay (cylinder 3 x 3) for the quantifications. bacillus subtilis, atcc 9372, was used as test organism. the used concentration range was of 50 to 200 μg/ml. the study demonstrated that the drug suffered degradation when submitted to the ultraviolet light, germicide light, solar luminosity, acid solution, basic solution and hydrogen peroxide solution. the results were analyzed by the analysis of variance (anova).
Performance characteristics of bioassay UV-spectrophotometry and high perfomance liquid chromatographic determination of gatifloxacin in tablets
Lopes, Cristiani Capistrano Gon?alves de Oliveira;Salgado, Hérida Regina Nunes;
Química Nova , 2008, DOI: 10.1590/S0100-40422008000700039
Abstract: the microbiological bioassay, uv-spectrophotometry and hplc methods for assaying gatifloxacin in tablets were compared. validation parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation were determined. beer's law was obeyed in the ranges 4.0-14.0 μg/ml for hplc and uv-spectrophotometric method, and 4.0-16.0 μg/ml for bioassay. all methods were reliable within acceptable limits for antibiotic pharmaceutical preparations being accurate, precise and reproducible. the bioassay and hplc are more specific than uv-spectrophotometric analysis. the application of each method as a routine analysis should be investigated considering cost, simplicity, equipment, solvents, speed, and application to large or small workloads.
Avalia o da qualidade da água purificada em farmácias magistrais da regi o de S o José do Rio Preto, SP
Andreia Haro Moreno,Greici Cristiani Gomes Tozo,Hérida Regina Nunes Salgado
Revista de Ciências Farmacêuticas Básica e Aplicada , 2011,
Abstract: A água é a matéria-prima mais utilizada na produ o de várias formas farmacêuticas, sendo um constituinte da própria formula o e exigindo para tal uma série de especifica es físico-químicas e microbiológicas. Além disso, é um insumo de utiliza o imprescindível para testes laboratoriais e procedimentos de limpeza de equipamentos e utensílios. O presente trabalho teve como objetivo verificar o grau de contamina o química e microbiana em água purificada utilizada em farmácias magistrais da regi o de S o José do Rio Preto, SP. As coletas foram realizadas segundo recomenda es da USP Pharmacopeia, com os devidos cuidados de assepsia, e as amostras encaminhadas imediatamente ao laboratório de controle de qualidade. Foram analisados vários parametros físico-químicos, tais como aspecto, pH, condutividade, resíduo por evapora o, am nia, cálcio, cloreto, metais pesados, sulfato e substancias oxidáveis, além de parametros microbiológicos, como contagem total de aeróbios e pesquisa de coliformes totais e termotolerantes e Pseudomonas aeruginosa. Os resultados indicaram alguns parametros de n o conformidade: em 10% das amostras analisadas para o pH e pesquisa de impurezas inorganicas, em 17% para condutividade, em 14% para substancias oxidáveis e em 20% para análise microbiológica, ressaltando a necessidade de maior rigor na produ o e qualidade da água purificada produzida e/ou armazenada nesses estabelecimentos farmacêuticos. Palavras-chave: água purificada. Controle de qualidade. Pesquisa de impurezas. Avalia o microbiológica. Farmácias magistrais. ABSTRACT Quality assessment of purified water used in pharmacies in S o José do Rio Preto, SP Water is the raw material used most in the production of diverse pharmaceutical forms and, being a constituent of the formulation itself, is subject to a number of physico-chemical and microbiological specifications. In addition, it is indispensable for laboratory tests and the cleaning of equipment and apparatus. The aim of this study was to ascertain the degree of physicochemical and microbiological contamination of purified water used in compounding pharmacies in the city of S o José do Rio Preto, SP, Brazil. Samples were taken as recommended in the USP Pharmacopeia, with careful aseptic technique, and sent immediately the to quality control laboratory. Physicochemical properties were analyzed, including appearance, pH, conductivity, residue after evaporation, ammonia, calcium, chloride, heavy metals, sulfate and oxidizable substances, and microbiological tests were performed: total aerobic microbial count and detecti
Estudo de perfil de dissolu o dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula
Marlus Chorilli,Ademir Alves Souza,Felipe Corrêa,Hérida Regina Nunes Salgado
Revista de Ciências Farmacêuticas Básica e Aplicada , 2010,
Abstract: Com o avan o da tecnologia e das pesquisas envolvendo libera o de fármacos, moderniza o de testes e maior ênfase da previsibilidade de efeitos terapêuticos por meio dos testes in vitro, os testes de dissolu o e os estudos de perfis de dissolu o têm ganhado cada vez mais importancia. Apesar de terem sido introduzidos inicialmente como uma forma de caracterizar o perfil de libera o de fármacos pouco solúveis, atualmente os testes de dissolu o fazem parte das monografias de quase todas as formas farmacêuticas sólidas orais. Este trabalho teve como objetivo estudar o perfil de dissolu o (porcentagem de fármaco dissolvido versus tempo) dos medicamentos de referência, genérico e similar contendo cefalexina 500 mg na forma farmacêutica de cápsulas. Foram analisadas três especialidades farmacêuticas (referência, genérico e similar), os quais foram submetidos ao teste de dissolu o e perfil de dissolu o in vitro. Os resultados obtidos no teste de dissolu o permitem concluir que as amostras encontraram-se de acordo com as especifica es e o perfil de dissolu o deste medicamento, nesta forma farmacêutica, é considerado de dissolu o rápida (85% de fármaco dissolvido em 15 minutos). Portanto, existe uma grande semelhan a entre as curvas obtidas, o que sugere que se trata de equivalentes farmacêuticos. Palavras-chave: Cefalexina. Perfil de dissolu o. Medicamento referência. Medicamento genérico. Medicamento similar. ABSTRACT Study of dissolution profile of the pioneer brand name, generic and similar brand name pharmaceutical products containing cephalexin in the form of capsules With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the
Stability Study of Darunavir Ethanolate Tablets Applying a New Stability-Indicating HPLC Method
Josilene Chaves Ruela Corrêa,Cristina Helena dos Reis Serra,Hérida Regina Nunes Salgado
Chromatography Research International , 2013, DOI: 10.1155/2013/834173
Abstract: Chemical and physical degradation of drugs may result in altered therapeutic efficacy and even toxic effects. Therefore, the aim of this work was to study the stability of darunavir and to develop and validate a liquid chromatography (LC) method to determine darunavir in raw material and tablets in the presence of degradation products. The novel method showed to be linear from 6.0 to 21.0?μg/mL, with high precision (CV < 2%) and accuracy (recuperation of 99.64%). It is simple and reliable, free of placebo interferences. The robustness of the method was evaluated by a factorial design using seven different parameters. Forced degradation study was done under alkaline, acidic, and oxidative stress at ambient temperature and by heating. The LC method was able to quantify and separate darunavir and its degradation products. Darunavir showed to be unstable under alkaline, acid, and oxidative conditions. The novelty of this study is understanding the factors that affect darunavir ethanolate stability in tablets, which is the first step to unravel the path to know the degradation products. The novel stability-indicating method can be used to monitor the drug and the main degradation products in low concentrations in which there is linearity. 1. Introduction According to the World Health Organization (WHO) AIDS epidemic updates, in 2009 new HIV infections were reduced by 17% over the previous eight years. Data from WHO also show that there are more people living with HIV than ever before as people are living longer due to the beneficial effects of antiretroviral therapy along with population growth [1]. WHO estimates that since the availability of effective treatment in 1996, some 2.9 million lives have been saved [1]. In accordance with Sharma and Garg, the current clinical therapeutic practice of using Highly Active Antiretroviral Therapy (HAART), is considered as one of the most significant advances in the field of HIV therapy [2]. As an important component of the HAART, darunavir (Figure 1), a synthetic nonpeptidic protease inhibitor developed by the pharmaceutical company Tibotec in 1998 [3], has demonstrated high efficacy against HIV [4, 5]. This compound was licensed in June 2006 in the United States and in February 2007 in the European Union [1]. The daily dose of darunavir (600?mg twice a day) has to be administered along with low dose (100?mg) of ritonavir as a booster and food [6] which contributes to better solubilization of the drug in the lumen [6]. Figure 1: Chemical structure of darunavir. Darunavir is marketed in ethanolate form under the brand
Performance characteristics of high performance liquid chromatography, first order derivative UV spectrophotometry and bioassay for fluconazole determination in capsules
Corrêa, Josilene Chaves Ruela;Reichman, Camila;Salgado, Hérida Regina Nunes;Vianna-Soares, Cristina Duarte;
Química Nova , 2012, DOI: 10.1590/S0100-40422012000300017
Abstract: the bioassay, first order derivative uv spectrophotometry and chromatographic methods for assaying fluconazole capsules were compared. they have shown great advantages over the earlier published methods. using the first order derivative, the uv spectrophotometry method does not suffer interference of excipients. validation parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation were determined. all methods were linear and reliable within acceptable limits for antibiotic pharmaceutical preparations being accurate, precise and reproducible. the application of each method as a routine analysis should be investigated considering cost, simplicity, equipment, solvents, speed, and application to large or small workloads.
Controle de qualidade da raiz de Operculina macrocarpa (Linn) Urb., Convolvulaceae
Michelin, Daniele Carvalho;Finati, Suellen Cristiane Gandolfo;Sacramento, Luis Vitor Silva;Vilegas, Wagner;Salgado, Hérida Regina Nunes;
Revista Brasileira de Farmacognosia , 2010, DOI: 10.1590/S0102-695X2010000100005
Abstract: considering the quality of the phytotherapic agents, it is important to point out that it includes rigorous attendance of the different steps of the development and production of these products, from the collection of the vegetable to the availability of the final product. in this work the quality control of the operculina macrocarpa (linn) urb. roots, popularly known as 'batata-de-purga', was carried out. pharmacopoeic and no pharmacopoeic methodologies were employed to physico-chemical and microbiological quality control. the obtained results showed that the roots presents a content of resin of 9,85%, the microbiological analysis did not present pathogenic growth among the other accomplished tests. the work stands out the importance of the establishment of norms for the quality control for the plants, so that they are found able to be used for phytotherapic reasons.
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