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‣ Magnetic images of pharmaceutical dosage forms in the human gastrointestinal tract

Baffa, O.; Corá, L. A.; Américo, M. F.; Fonseca, P. R.; Oliveira, R. B.; Miranda, J. R A
Fonte: Universidade Estadual Paulista Publicador: Universidade Estadual Paulista
Tipo: Conferência ou Objeto de Conferência Formato: 7254-7257
Português
Relevância na Pesquisa
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Oral administration with solid dosage forms is a common route in the drug therapy widely used. The drug release by the disintegration process occurs in several gastrointestinal tract (GIT) regions. AC Biosusceptometry (ACB) was originally proposal to characterize the disintegration process of tablets in vitro and in the human stomach, through changes in magnetic signals. The aim of this work was to employ a multisensor ACB system to monitoring magnetic tablets and capsules in the human GIT and to obtain the magnetic images of the disintegration process. The ACB showed accuracy to quantify the gastric residence time, the intestinal transit time and the magnetic images allowed to visualize the disintegration of magnetic formulations in the GIT. The ACB is a non-invasive, radiation free technique, completely safe and harmless to the volunteers and had demonstrated potential to evaluate pharmaceutical dosage forms in the human gastrointestinal tract. © 2005 IEEE.

‣ Non-conventional applications of computerized tomography: Analysis of solid dosage forms produced by pharmaceutical industry

De Oliveira Jr., José Martins; Germano Martins, Antonio César
Fonte: Universidade Estadual Paulista Publicador: Universidade Estadual Paulista
Tipo: Conferência ou Objeto de Conferência Formato: 153-159
Português
Relevância na Pesquisa
68.64386%
X-ray computed tomography (CT) refers to the cross-sectional imaging of an object measuring the transmitted radiation at different directions. In this work, we describe a non-conventional application of computerized tomography: visualization and improvements in the understanding of some internal structural features of solid dosage forms. A micro-CT X-ray scanner, with a minimum resolution of 30 μm was used to characterize some pharmaceutical tablets, granules, controlled-release osmotic tablet and liquid-filled soft-gelatin capsules. The analysis presented in this work are essentially qualitative, but quantitative parameters, such as porosity, density distribution, tablets dimensions, etc. could also be obtained using the related CT techniques. © 2010 American Institute of Physics.

‣ A ressonância magnética no estudo da desintegração de comprimidos marcados com açaí (Euterpe oleracea)

Souza, Luiz Gustavo Rubi de
Fonte: Universidade Estadual Paulista (UNESP) Publicador: Universidade Estadual Paulista (UNESP)
Tipo: Dissertação de Mestrado Formato: 45 f.
Português
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Pós-graduação em Biologia Geral e Aplicada - IBB; Avaliar formas farmacêuticas sólidas in vivo fornece um entendimento mais profundo quando um efeito sistêmico ou local é desejado. Geralmente, estes estudos são realizados por meio da cintilografia e técnicas biomagnéticas. A Ressonância Magnética (RM) vem sendo aplicada em tecnologia farmacêutica sendo que estes estudos são realizados com comprimidos marcados por partículas de óxido de ferro ou por gadolíneo em pó. Este estudo propõe a utilização da RM para monitorar o processo de desintegração in vitro e in vivo de comprimidos contendo açaí (Euterpe oleracea) como agente de contraste natural. O açaí é uma fruta presente em abundância na região norte do Brasil com a propriedade de atuar como agente de contraste oral em imagens obtidas por RM. Comprimidos obtidos com diferentes desintegrantes (croscarmelose sódica, crospovidona e mistura efervescente) foram marcados com açaí e revestidos com uma solução de polímero pH-independente. As formas farmacêuticas foram avaliadas in vitro e in vivo em um equipamento de RM de 0,5 T. Os resultados mostraram que o açaí é um forte agente de contraste e pode ser empregado em estudos farmacêuticos. Foi possível definir a imagem do comprimido e quantificar o processo de desintegração. Não foram encontradas diferenças (p>0...

‣ Validation of HPLC, DPPH• and nitrosation methods for mesalamine determination in pharmaceutical dosage forms; Validação dos métodos de CLAE, DPPH• e nitrosação para determinação de mesalazina em formas farmacêuticas

Rafael, Janice Aparecida; Jabor, José Roberto; Casagrande, Rúbia; Georgetti, Sandra Regina; Borin, Maria de Fátima; Fonseca, Maria José Vieira
Fonte: Divisão de Biblioteca e Documentação do Conjunto das Químicas da Universidade de São Paulo Publicador: Divisão de Biblioteca e Documentação do Conjunto das Químicas da Universidade de São Paulo
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
68.34078%
Mesalazina (ácido 5-aminosalicílico, 5-ASA) é utilizado devido seu efeito local no tratamento de doença inflamatória intestinal. Assim, o objetivo deste trabalho foi comparar e validar três métodos analíticos para o controle de qualidade de comprimidos comerciais revestidos contendo 5-ASA: cromatografia líquida de alta eficiência (CLAE), radical 1,1-difenil-2-picril-hidrazil (DPPH•) e nitrosação. Os parâmetros linearidade, precisão e exatidão foram estudados neste trabalho. CLAE com detecção ultravioleta em 254 nm foi realizada utilizando coluna C18 e a eluição em fase móvel constituída de tampão fosfato monobásico 30 mmol/L (pH 7,0) e metanol (70:30; v/v), com 25% de sulfato hidrogênio de tetrabutilamônio. Para o método de DPPH• utilizou-se tampão acetato 100 mmol/L, pH 5,5, álcool etílico e 250 µmol/L solução etanólica de DPPH• a 517 nm. Para o método de nitrosação utilizou-se um eletrodo de platina e um padrão de nitrito de sódio 0.1 mol/L como solução titulante. Repetibilidade (intra-dia) e precisão intermediária (inter-dia), expressado como DPR, foi menor que 3%. A recuperação experimental foi entre 72,5 e 99,9%. Análise estatística por "one-way" ANOVA, seguida de comparação múltipla do teste de Bonferroni...

‣ Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms

Reddy,Gosula Venkat Ram; Reddy,Bobba Venkateswara; Haque,Syed Wasimul; Gautam,Haum Dutt; Kumar,Poonam; Kumar,Avvaru Praveen; Park,Jung Hag
Fonte: Sociedade Brasileira de Química Publicador: Sociedade Brasileira de Química
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/01/2011 Português
Relevância na Pesquisa
68.81803%
The present work describes a novel stability-indicating reversed-phase ultra performance liquid chromatography method for the separation and quantification of rosuvastatin (RSV) and its related impurities in the pharmaceutical dosage forms under forced degradation conditions. An unknown degradation impurity detected in the acid degradation was identified by using quadrupole time-of-flight mass spectrometry. The chromatographic separation was carried out on C-18 column (100 x 2.1 mm, 1.7 μm) using isocratic elution with methanol and 0.1% trifluoroacetic acid (50:50). The total run time was 12 min within which RSV as well as all related impurities and degradation products were separated. The developed method was validated for RSV and related impurities in pharmaceutical dosage forms.

‣ Electrochemical studies of olmesartan medoxomil and its detection in pharmaceutical dosage forms and biological fluids by cathodic adsorptive stripping voltammetric method

Öztürk,Funda; Küçükkolbaşı,Semahat; Kaçar,Ceren; Kılıç,Esma
Fonte: Sociedade Brasileira de Química Publicador: Sociedade Brasileira de Química
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/05/2014 Português
Relevância na Pesquisa
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The electrochemical properties of olmesartan (OLME) were investigated by cyclic voltammetry (CV) and differential pulse voltammetry (DPV) at hanging mercury drop electrode (HMDE). All studies were based on the irreversible and adsorption-controlled electrochemical reduction signal of OLME at about -1.2 and -1.5 V vs. Ag/AgCl at pH 5.0 in Britton-Robinson (BR) buffer. This adsorptive character of the molecule was used to develop a novel, fully validated, rapid, selective and simple differential pulse cathodic adsorptive stripping voltammeric (DPCAdSV) method for the direct determination of OLME in pharmaceutical dosage form and human urine without time-consuming steps prior to drug assay. Peak current of electrochemical reduction of OLME was found to vary linearly with the concentration in the range from 4.7 × 10-8 mol L-1 (0.0262 µg mL-1) to 8.3 × 10-6 mol L-1 (4.636 µg mL-1). In this method, limit of quantification (LOQ) was found to be 5.1 × 10-7 mol L-1 (0.284 µg mL-1). The method was applied to determine the content of OLME in commercial pharmaceutical preparation and spiked human urine. It was found to be highly accurate and precise, having a relative standard deviation of less than 10% for all applications.

‣ Validation of HPLC, DPPH• and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Rafael,Janice Aparecida; Jabor,José Roberto; Casagrande,Rúbia; Georgetti,Sandra Regina; Borin,Maria de Fátima; Fonseca,Maria José Vieira
Fonte: Divisão de Biblioteca e Documentação do Conjunto das Químicas da Universidade de São Paulo Publicador: Divisão de Biblioteca e Documentação do Conjunto das Químicas da Universidade de São Paulo
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2007 Português
Relevância na Pesquisa
98.81804%
Mesalamine (5-aminosalicylic acid, 5-ASA) is used because of its local effects in the treatment of inflammatory bowel disease. Therefore, the aims of this work were to compare and validate three analytical methods for the quality control of commercial coated tablets containing 5-ASA: high performance liquid chromatography (HPLC), 1,1-diphenyl-2-picrylhydrazyl radicals (DPPH•) and nitrosation. The parameters linearity, precision and accuracy were studied in this work. HPLC with ultraviolet detection at 254 nm was carried out with a C18 column and a mobile phase constituted of 30 mmol/L monobasic phosphate buffer (pH 7.0) and methanol (70:30; v/v), with 25% tetrabutylammonium hydrogen sulphate. The DPPH• method was performed at 517 nm and using 100 mmol/L acetate buffer, pH 5.5, ethanol and 250 µmol/L ethanolic solution of DPPH•. The nitrosation method was accomplished by using a platinum electrode and standard 0.1 mol/L sodium nitrite as titrant solution. Repeatability (intra-day) and intermediate precision (inter-day), expressed as RSD, were lower than 3%. The experimental recoveries were between 72.5 and 99.9%. Statistical analysis by one-way ANOVA, followed by the multiple comparison test of Bonferroni showed no significant difference among the three methods. All proposed methods can be used for the reliable quantitation of 5-ASA in pharmaceutical dosage forms.

‣ Transit of pharmaceutical dosage forms through the small intestine.

Davis, S S; Hardy, J G; Fara, J W
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /08/1986 Português
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The gastrointestinal transit of pharmaceutical dosage forms has been measured in 201 studies in normal subjects using gamma scintigraphy. Solutions, small pellets, and single units (matrix tablets and osmotic pumps) were administered with different amounts of food in the stomach, ranging from fasted state to heavy breakfast. Gastric emptying was affected by the nature of the dosage form and the presence of food in the stomach. Solutions and pellets were emptied even when the stomach was in the digestive mode, while single units were retained for long periods of time, depending on the size of the meal. In contrast, measured intestinal transit times were independent of the dosage form and fed state. The small intestinal transit time of about three hours (mean +/- 1 h SEM) has implications for the design of dosage forms for the sustained release of drugs in specific positions in the gastrointestinal tract.

‣ Pangamic Acid (Vitamin B15, Pangametin, Sopangamine): Its Composition and Determination in Pharmaceutical Dosage Forms

French, W. N.; Levi, Leo
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 28/05/1966 Português
Relevância na Pesquisa
68.34078%
Pangamic acid is shown to be a mixture of variable composition. Criteria of identity and methods of analysis are described for five pharmaceutical dosage forms. Experimental results indicate that the products are not uniform in composition and that composition does not conform to label claims. No satisfactory preclinical drug application for any such preparation has so far been submitted to the Food and Drug Directorate.

‣ Reverse Phase High Performance Liquid Chromatographic Method for the Analysis of Letrozole in Pharmaceutical Dosage Forms

Laha, T. K.; Patnaik, R. K.; Sen, S.
Fonte: Medknow Publications Publicador: Medknow Publications
Tipo: Artigo de Revista Científica
Publicado em //2008 Português
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A rapid and sensitive reverse phase high performance liquid chromatographic method is depicted for the qualitative and quantitative assay of letrozole in pharmaceutical dosage forms. Letrozole was chromatographed on a reverse phase C18 column with a mobile phase consisting of acetonitrile and phosphate buffer (pH 7.8) in the ratio of 70:30 v/v. The mobile phase was pumped at a flow rate of 1 ml/min. Acenaphthene was used as an internal standard and the eluents were monitored at 232 nm. The retention time of the drug was 3.385 min. With this method, linearity was observed in the range of 10-100 μg/ml. The LOD and LOQ were found to be 0.51 μg/ml and 1.52 μg/ml, respectively. The method was found to be applicable for analysis of drug in tablets. The results of the analysis were validated statistically.

‣ Visible Spectrophotometric Estimation of Diacerein in Bulk and Pharmaceutical Dosage Forms

Sivakumar, R; Nallasivan, PK; Saranya, KC; Sam, Solomon WD; Akelesh, T; Venkatnarayanan, R
Fonte: Medknow Publications Publicador: Medknow Publications
Tipo: Artigo de Revista Científica
Publicado em //2010 Português
Relevância na Pesquisa
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Two simple, sensitive, accurate, rapid, and economical spectrophotometric methods have been developed for the estimation of diacerein in Pharmaceutical dosage forms. Method A is based on the reaction of diacerein with Folin-Ciocalteu reagent, in the presence of 0.5 N sodium hydroxide solution, giving a pink-colored chromogen, which shows maximum absorbance at 512 nm against reagent blank, while method B is based on the oxidation of diacerein with potassium permanganate in an alkaline medium giving a pink-colored chromogen, which shows maximum absorption at 497.5 nm. Beer’s law was obeyed in the concentration range of 4 – 20 µg/ml for both methods A and B. Results of the analysis were validated statistically, and by recovery studies.

‣ New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms

Rao, Kareti Srinivasa; Kumar, Keshar Nargesh; Joydeep, Datta
Fonte: Österreichische Apotheker-Verlagsgesellschaft Publicador: Österreichische Apotheker-Verlagsgesellschaft
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
68.34078%
A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5–200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.

‣ HPTLC METHOD DEVELOPMENT AND VALIDATION OF TRANDOLAPRIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Sreekanth, N.; Awen, Bahlul Z.; Rao, Ch. Babu
Fonte: Medknow Publications & Media Pvt Ltd Publicador: Medknow Publications & Media Pvt Ltd
Tipo: Artigo de Revista Científica
Publicado em //2010 Português
Relevância na Pesquisa
68.64386%
A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and completely validated for the estimation of trandolapril in bulk and pharmaceutical dosage forms. Quantification of trandolapril was carried out with percolated silica gel 60F254 as stationary phase using mobile phase consisting of Chloroform: Methanol: Acetic acid (8:1.5:0.5 v/ v/ v) and scanned in Absorbancei Reflectance mode at 212 nm using Camag TLC scanner 3 with WinCAT software. The Rf value of trandolapril was found to be 0.54 (±0.03). The proposed method has permitted the quantification of trandolapril over the linearity range of 25-150 ng/spot and its percentage recovery was found to 99.7%. The intraday and inter day precision were found to be 1.26% and 1.4%, respectively. The limit of detection and the limit of quantification were found to be 18 ng/ spot and 54 ng/ spot, respectively. The proposed method can be successfully applied for the estimation of drug content of different marketed formulations simultaneously on a single plate and provides a faster and cost effective quality control tool for routine analysis of trandolapril as bulk drug and in tablet dosage forms.

‣ Simultaneous Determination of Miconazole Nitrate and Metronidazole in Different Pharmaceutical Dosage Forms by Gas Chromatography and Flame Ionization Detector (GC-FID)

Ashour, Safwan; Kattan, Nuha
Fonte: Master Publishing Group Publicador: Master Publishing Group
Tipo: Artigo de Revista Científica
Publicado em /03/2010 Português
Relevância na Pesquisa
68.34078%
A simple, rapid and precise gas chromatographic method has been developed for the simultaneous determination of miconazole nitrate (MIZ) and metronidazole (MNZ) in tablets and ovules, using a capillary column AE.SE-54 (15 m × 0.53 mm, i.d.) and nitrogen as a carrier gas at a flow rate of 9 mL min−1. The oven temperature was programmed at 140°C for 3 min, with a rise of 40°C min−1 up to 180°C (held for 2 min) and then increased to a final temperature of 250°C. The injector and detector port temperatures were maintained at 260°C. Detection was carried out using flame ionization detector. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. The retention times were about 3.50 and 12.90 min for MNZ and MIZ, respectively. Linearity ranges were 50.0–6030.0 and 62.5–2000.0 μg mL−1 for MNZ and MIZ, with limit of detection values of 2.5 and 3.1 μg mL−1, respectively. Correlation coefficients (R2) of the regression equations were greater than 0.999 in all cases. No interference from any components of pharmaceutical dosage forms or degradation products was observed. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the simultaneous quantitative analysis of MIZ and MNZ in tablets and ovules.

‣ Development and Validation of a Precise, Single HPLC Method for the Determination of Tolperisone Impurities in API and Pharmaceutical Dosage Forms

Raju, Thummala Veera Raghava; Seshadri, Raja Kumar; Arutla, Srinivas; Mohan, Tharlapu Satya Sankarsana Jagan; Rao, Ivaturi Mrutyunjaya; Nittala, Someswara Rao
Fonte: Österreichische Apotheker-Verlagsgesellschaft Publicador: Österreichische Apotheker-Verlagsgesellschaft
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
68.34078%
A novel, sensitive, stability-indicating HPLC method has been developed for the quantitative estimation of Tolperisone-related impurities in both bulk drugs and pharmaceutical dosage forms. Effective chromatographic separation was achieved on a C18 stationary phase with a simple mobile phase combination delivered in a simple gradient programme, and quantitation was by ultraviolet detection at 254 nm. The mobile phase consisted of a buffer and acetonitrile delivered at a flow rate 1.0 ml/min. The buffer consisted of 0.01 M potassium dihydrogen phosphate with the pH adjusted to 8.0 by using diethylamine. In the developed HPLC method, the resolution between Tolperisone and its four potential impurities was found to be greater than 2.0. Regression analysis showed an R value (correlation coefficient) of greater than 0.999 for the Tolperisone impurities. This method was capable of detecting all four impurities of Tolperisone at a level of 0.19 μg/mL with respect to the test concentration of 1000 μg/mL for a 10 µl injection volume. The tablets were subjected to the stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. Considerable degradation was found to occur in base hydrolysis, water hydrolysis, and oxidation. The stress samples were assayed against a qualified reference standard and the mass balance was found to be close to 100%. The established method was validated and found to be linear...

‣ Derivative spectrophotometric method for simultaneous determination of clindamycin phosphate and tretinoin in pharmaceutical dosage forms

Barazandeh Tehrani, Maliheh; Namadchian, Melika; Fadaye Vatan, Sedigheh; Souri, Effat
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
Publicado em 10/04/2013 Português
Relevância na Pesquisa
68.34078%
A derivative spectrophotometric method was proposed for the simultaneous determination of clindamycin and tretinoin in pharmaceutical dosage forms. The measurement was achieved using the first and second derivative signals of clindamycin at (1D) 251 nm and (2D) 239 nm and tretinoin at (1D) 364 nm and (2D) 387 nm.

‣ Development of a Simple RP-HPLC-UV Method for Determination of Azithromycin in Bulk and Pharmaceutical Dosage forms as an Alternative to the USP Method

Ghari, Tayebeh; Kobarfard, Farzad; Mortazavi, Seyed Alireza
Fonte: Shaheed Beheshti University of Medical Sciences Publicador: Shaheed Beheshti University of Medical Sciences
Tipo: Artigo de Revista Científica
Publicado em //2013 Português
Relevância na Pesquisa
68.81803%
The present study was designed to develop a simple, validated liquid chromatographic method for the analysis of azithromycin in bulk and pharmaceutical dosage forms using ultraviolet detector. The best stationary phase was determined as C18 column, 5 μm, 250 mm × 4.6 mm. Mobile phase was optimized to obtain a fast and selective separation of the drug. Flow rate was 1.5 mL/min, Wavelength was set at 210 nm and the volume of each injection was 500 μL. An isocratic methanol/buffer mobile phase at the ratio of 90:10 v/v gave the best separation and resolution. The proposed method was accurate, precise, sensitive, and linear over a wide range of concentration of azithromycin. The developed method has the advantage of using UV detector compared to the USP method in which electrochemical detector has been used. The validated method was successfully applied to the determination of azithromycin in bulk and pharmaceutical dosage forms.

‣ Development and Validation of a Reversed-phase HPLC Method for Assay of the Decapeptide Cetrorelix Acetate in Bulk and Pharmaceutical Dosage Forms

Hooshfar, Shirin; Mortazavi, Seyed Alireza; Piryaei, Mohammad; Ramandi Darzi, Hossein; Shahsavari, Nahid; Kobarfard, Farzad
Fonte: Shaheed Beheshti University of Medical Sciences Publicador: Shaheed Beheshti University of Medical Sciences
Tipo: Artigo de Revista Científica
Publicado em //2014 Português
Relevância na Pesquisa
68.81803%
A gradient reversed-phase high performance liquid chromatography (HPLC) method was developed for the assay of cetrorelix acetate, a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity used in infertility treatment. The HPLC method, which is used to determine cetrorelix in bulk and pharmaceutical dosage forms, was validated per ICH guidelines. The chromatographic separation was achieved on a C18 reversed-phase column using acetonitrile, water and trifluoroacetic acid (TFA) as mobile phase and wavelength was set at 275 nm. The calibration curve was linear (r2 = 0.999) over cetrorelix concentrations ranging from 62.50 to 12.50 μg/mL (n = 6). The limits of detection (LOD) and quantification (LOQ) were calculated from the peak-to-noise ratio as 15.6 and 62.5 μg/mL, respectively. The method had an accuracy of > 97% and intra- and inter-day RSD of < 0.3% and < 1.6%, respectively and was validated with excellent specificity, sensitivity, and stability. The validated method was successfully applied for determination of cetrorelix in bulk and pharmaceutical dosage forms.

‣ Simultaneous determination of linagliptin and metformin by reverse phase-high performance liquid chromatography method: An application in quantitative analysis of pharmaceutical dosage forms

Vemula, Prathyusha; Dodda, Dilip; Balekari, Umamahesh; Panga, Shyam; Veeresham, Ciddi
Fonte: Medknow Publications & Media Pvt Ltd Publicador: Medknow Publications & Media Pvt Ltd
Tipo: Artigo de Revista Científica
Publicado em //2015 Português
Relevância na Pesquisa
68.81803%
To enhance patient compliance toward treatment in diseases like diabetes, usually a combination of drugs is prescribed. Therefore, an anti-diabetic fixed-dose combination of 2.5 mg of linagliptin 500 mg of metformin was taken for simultaneous estimation of both the drugs by reverse phase-high performance liquid chromatography (RP-HPLC) method. The present study aimed to develop a simple and sensitive RP-HPLC method for the simultaneous determination of linagliptin and metformin in pharmaceutical dosage forms. The chromatographic separation was designed and evaluated by using linagliptin and metformin working standard and sample solutions in the linearity range. Chromatographic separation was performed on a C18 column using a mobile phase of 70:30 (v/v) mixture of methanol and 0.05 M potassium dihydrogen orthophosphate (pH adjusted to 4.6 with orthophosphoric acid) delivered at a flow rate of 0.6 mL/min and UV detection at 267 nm. Linagliptin and metformin shown linearity in the range of 2-12 μg/mL and 400–2400 μg/mL respectively with correlation co-efficient of 0.9996 and 0.9989. The resultant findings analyzed for standard deviation (SD) and relative standard deviation to validate the developed method. The retention time of linagliptin and metformin was found to be 6.3 and 4.6 min and separation was complete in <10 min. The method was validated for linearity...

‣ Validação dos métodos de CLAE, DPPH• e nitrosação para determinação de mesalazina em formas farmacêuticas; Validation of HPLC, DPPH• and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Rafael, Janice Aparecida; Jabor, José Roberto; Casagrande, Rúbia; Georgetti, Sandra Regina; Borin, Maria de Fátima; Fonseca, Maria José Vieira
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; Artigo Avaliado pelos Pares Formato: application/pdf
Publicado em 01/03/2007 Português
Relevância na Pesquisa
98.81804%
Mesalazina (ácido 5-aminosalicílico, 5-ASA) é utilizado devido seu efeito local no tratamento de doença inflamatória intestinal. Assim, o objetivo deste trabalho foi comparar e validar três métodos analíticos para o controle de qualidade de comprimidos comerciais revestidos contendo 5-ASA: cromatografia líquida de alta eficiência (CLAE), radical 1,1-difenil-2-picril-hidrazil (DPPH•) e nitrosação. Os parâmetros linearidade, precisão e exatidão foram estudados neste trabalho. CLAE com detecção ultravioleta em 254 nm foi realizada utilizando coluna C18 e a eluição em fase móvel constituída de tampão fosfato monobásico 30 mmol/L (pH 7,0) e metanol (70:30; v/v), com 25% de sulfato hidrogênio de tetrabutilamônio. Para o método de DPPH• utilizou-se tampão acetato 100 mmol/L, pH 5,5, álcool etílico e 250 µmol/L solução etanólica de DPPH• a 517 nm. Para o método de nitrosação utilizou-se um eletrodo de platina e um padrão de nitrito de sódio 0.1 mol/L como solução titulante. Repetibilidade (intra-dia) e precisão intermediária (inter-dia), expressado como DPR, foi menor que 3%. A recuperação experimental foi entre 72,5 e 99,9%. Análise estatística por "one-way" ANOVA, seguida de comparação múltipla do teste de Bonferroni...