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Registros recuperados: 8
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Development and validation of UV spectrophotometric method for orbifloxacin assay and dissolution studies BJPS
Cazedey,Edith Cristina Laignier; Salgado,Hérida Regina Nunes.
New, simple and cost effective UV-spectrophotometric method was developed for the estimation of orbifloxacin in pharmaceutical formulation. Orbifloxacin was estimated at 290 nm in 0.5 M hydrochloric acid. Linearity range was found to be 1.0-6.0 μg mL-1. The method was tested and validated for various parameters according to main guidelines. The proposed method was successfully applied for the determination of orbifloxacin in tablets. The results demonstrated that the procedure is accurate, precise and reproducible, while being simple, economical and less time consuming. It can be suitably applied for the estimation of orbifloxacin in routine quality control and dissolution studies.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Medicines/quality control; Medicines/dissolution; Orbifloxacin/determination; UV spectrophotometry/quantitative analysis/validation.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000300457
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Determination of carbamazepine in pharmaceutical formulations BJPS
Solon,Lílian Grace da Silva; Oliveira,Ana Isabel Maia de; Guerra,Gerlane Coelho Bernardo; Soares,Luiz Alberto Lira; Araújo,Aurigena Antunes de.
The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Carbamazepine; Medicines/quality control; Generic medicines; Similar medicines; Medicines/magistral formulation.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000300014
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Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria BJPS
Santos,Olímpia Maria Martins; Reis,Maria Esther Dias; Jacon,Jennifer Tavares; Lino,Mônica Esselin de Sousa; Simões,Juliana Savioli; Doriguetto,Antonio Carlos.
Polymorphism in solids is a common phenomenon in drugs, which can lead to compromised quality due to changes in their physicochemical properties, particularly solubility, and, therefore, reduce bioavailability. Herein, a bibliographic survey was performed based on key issues and studies related to polymorphism in active pharmaceutical ingredient (APIs) present in medications from the Farmácia Popular Rede Própria. Polymorphism must be controlled to prevent possible ineffective therapy and/or improper dosage. Few mandatory tests for the identification and control of polymorphism in medications are currently available, which can result in serious public health concerns.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Polymorphism; Medicines/quality control; Medicines/solubility; Medicines/bioavailability.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000100002
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Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC BJPS
Araújo,Adriano Antunes Souza; Bezerra,Marília dos Santos; Storpirtis,Sílvia; Matos,Jivaldo do Rosário.
The determination of chemical purity, melting range, and variation of enthalpy in the process of characterizing medicines is one of the principal requirements evaluated in quality control of the pharmaceutical industry. In this study, the method of purity determination using DSC was outlined, as well as the application of this technique for the evaluation of commercial samples of zidovudine (AZT) (raw material) supplied by different laboratories. To this end, samples from six different laboratories (A, B, C, D, E, and F) and the standard reference (R) from the United States Pharmacopeia (USP) were analyzed. The DSC curves were obtained in the temperature range of 25 to 200 ºC under the dynamic atmosphere of N2 (50 mL min-1), heating rate of β=2 ºC min-1,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Zidovudine/purity determination; Differential scanning calorimetry; Thermal analysis; Medicines/quality control; Medicines/qualitative analysis.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100005
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Stability-indicating liquid chromatographic and UV spectrophotometric methods for the quantification of ciprofibrate in capsules and tablets BJPS
Hellwig,Fernanda Macke; Reis,Rafael Henrique Dias; Barbosa,Suzana Del Rosso; Malesuik,Marcelo Donadel.
This study describes the development and evaluation of stability-indicating liquid chromatographic (LC) and UV spectrophotometric methods for the quantification of ciprofibrate (CPF) in tablets and capsules. Isocratic LC separation was achieved on a RP18 column using a mobile phase of o-phosphoric acid (0.1% v/v), adjusted to pH 3.0 with triethylamine (10% v/v) and acetonitrile (35:65 v/v), with a flow rate of 1.0 mL min-1. Detection was achieved with a photodiode array detector at 233 nm. For the spectrophotometric analysis, ethanol and water were used as the solvent and a wavelength of 233 nm was selected for the detection. The methods were validated according to International Conference on Harmonization (ICH) guidelines for validating analytical...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Ciprofibrate/tablets/quality control; Ciprofibrate/capsules/quality control; UV Spectrophotometry/quantitative analysis; Liquid chromatography/stability study; Medicines/quality control.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000100221
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Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method BJPS
Martins,Magda Targa; Paim,Clésio Soldatelli; Steppe,Martin.
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.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Lamotrigine; Dissolution test/validation; Medicines/quality control.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200003
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Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry BJPS
Pedroso,Tahisa Marcela; Salgado,Hérida Regina Nunes.
A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2=0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies....
Tipo: Info:eu-repo/semantics/article Palavras-chave: Cefazolin sodium/determination; High performance liquid chromatography/reverse-phase/quantitative analysis; Pharmaceutical industry/quality control; Cefalosporine/quality control; Medicines/quality control.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000100022
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Validation of a spectrophotometric method to determine ciprofibrate content in tablets BJPS
Nascimento,Guilherme Nobre Lima do; Rosa,Daniel Lerner da; Nishijo,Hisao; Aversi-Ferreira,Tales Alexandre.
Ciprofibrate is a drug indicated in cases of hypertriglyceridemia and mixed hyperlipidemia, but no monographs are available in official compendia for the analysis of this substance in tablets. The objective of this work was to develop and validate a spectrophotometric method for routine analysis of ciprofibrate in tablets. In this study, commercial and standard ciprofibrate were used, as well as placebo in absolute ethanol, analyzed by UV spectrophotometer. All tests followed the rules of Resolution RE-899, 2003. The results showed that the developed and validated method offers low cost, easy implementation, precision and accuracy, and may be included in the routine of quality control laboratories.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Ciprofibrate/analysis; Spectrophotometric method/medicines analysis; Medicines/quality control.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000100004
Registros recuperados: 8
Primeira ... 1 ... Última
 

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