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Search Results: 1 - 10 of 22467 matches for " Method Validation "
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RP-HPLC Method for the Simultaneous Determination of Lisinopril and NSAIDs in API, Pharmaceutical Formulations and Human Serum  [PDF]
Najma Sultana, M. Saeed Arayne, Rubina Siddiqui, Safila Naveed
American Journal of Analytical Chemistry (AJAC) , 2012, DOI: 10.4236/ajac.2012.32021
Abstract: High performance liquid chromatographic method was developed valdated and applied for the simultaneous determi- nation of lisinopril and NSAIDs in bulk, pharmaceuticals formulations and human serum. A Purospher star C18 (5 μm, 25 × 0.46 cm) column was used with mobile phase consisting of methanol: water: acetonitrile (80:17.5:2.5 v/v, pH 3.0) and quantitative evaluation was performed at 225 nm with a flow rate of 1.0 mL?min–1. The retention time of lisinopril was 2.2 min while naproxen, flurbiprofen, diclofenac sodium and mefenamic acid were found to be 4.0, 4.5, 5.0 and 6.7 min respectively. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines. The method is selective, precise, accurate and can be used for analysis of pharmaceutical preparations in quality control and clinical laboratories.
Development of a Performant Method for Glucocapparin Determination in Boscia senegalensis Lam Ex. Poir.: A Study of the Variability  [PDF]
Momar Talla Gueye, Dogo Seck, Abdoulaye Diallo, Danny Trisman, Christophe Fischer, Jean-Paul Barthelemy, Jean-Paul Wathelet, Georges Lognay
American Journal of Analytical Chemistry (AJAC) , 2013, DOI: 10.4236/ajac.2013.42014

This study describes a glucocapparin determination method. Based on rapeseed determination of glucosinolate (GSL), the equation of the average straight regression line is Y = 100.42X 0.03 (R2 = 0.9998). Enzymatic hydrolysis of glucocapparin extracted from leaves and fruits of B. senegalensis, analyzed by SPME-GC-MS confirmed the presence of methylisothiocyanate as the main hydrolysis glucocapparin product. Monitoring glucocapparin contents in B. senegalensis leaves and fruits collected in 4 localities in Senegal showed differences between organs according localities and periods of harvest. Glucocapparin content was very high in dry season particularly in January and the lowest rates were recorded during the rainy period between August and November.

Valida??o de método para determina??o de resíduos de amoxicilina aplicado à valida??o de limpeza em indústria farmacêutica de penicilanicos
Gomes, Maria Luiza Pinheiro Costa;Souza, Scheilla Vitorino Carvalho de;
Química Nova , 2010, DOI: 10.1590/S0100-40422010000400038
Abstract: the aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. linearity was demonstrated between 2.5 and 17.5 μg/ml, without matrix effects. mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. the theoretical limits of detection and quantification were 0.133 and 0.442 μg/ml, respectively. the studied method was suitable for cleaning control purpose within good manufacturing practices.
Development and validation of a simple and rapid capillary zone electrophoresis method for determination of nnrti nevirapine in pharmaceutical formulations
Zanolli Filho, Luiz A.;Galdez, Cristiane R.;Silva, Claudinei A.;Tavares, Marina F. M.;Costa, Diana M.;Aurora-Prado, María S.;
Journal of the Brazilian Chemical Society , 2011, DOI: 10.1590/S0103-50532011001000024
Abstract: a simple and fast capillary zone electrophoresis (cze) method has been developed and validated for quantification of a non-nucleoside reverse transcriptase inhibitor (nnrti) nevirapine, in pharmaceuticals. the analysis was optimized using 10 mmol l-1 sodium phosphate buffer ph 2.5, +25 kv applied voltage, hydrodynamic injection 0.5 psi for 5 s and direct uv detection at 200 μm. diazepam (50.0 μg ml-1) was used as internal standard. under these conditions, nevirapine was analyzed in approximately less than 2.5 min. the analytical curve presented a coefficient of correlation of 0.9994. limits of detection and quantification were 1.4 μg ml-1 and 4.3 μg ml-1, respectively. intra- and inter-day precision expressed as relative standard deviations were 1.4% and 1.3%, respectively and the mean recovery was 100.81%. the active pharmaceutical ingredient was subjected to hydrolysis (acid, basic and neutral) and oxidative stress conditions. no interference of degradation products and tablet excipients were observed. this method showed to be rapid, simple, precise, accurate and economical for determination of nevirapine in pharmaceuticals and it is suitable for routine quality control analysis since ce offers benefits in terms of quicker method development and significantly reduced operating costs.
Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents
Guimar?es, Rosane Cuber;Leal, Alaide Aline Xavier;
Brazilian Archives of Biology and Technology , 2006, DOI: 10.1590/S1516-89132006000200010
Abstract: method validation is the process used to confirm that the analytical procedures employed for a specific test is able to produce reliable and replicable results. an analytical method should be conducted in order to demonstrate that it is suitable for its intended use [1]. the aim of this present work is to demonstrate and evaluate the suitability of method validation. the analytical validation discussed herein was conducted by prescribed protocol, using 3 different batches of measles's vaccine diluents. all of the stipulated validation parameters: linearity, repeatability, reproducibility (intermediate precision) and accuracy were met. additionally, this study demonstrated the method's capability for the determining endotoxin levels in measles's vaccine diluents and its further use in apirogenic water samples.
Validación del método analítico para el control de la calidad y estudio de estabilidad de fenilefrina 10 % colirio
Monteagudo Licea,Raiza; García Pe?a,Caridad Margarita; Botet García,Martha; Troche Concepción,Yenilen; Montes de Oca Porto,Yanet;
Revista Cubana de Farmacia , 2010,
Abstract: phenylephrine is used like mydiatric in eye examinations and other ophthalmic procedures. it is used as vasoconstrictor with local anesthetic agents. in present paper a high ressolution liquid chromatography analytical method was validated to quality control and stability studies of 10 % phenylephrine (eyedrops). mathod was based in separation of active principle through a lichrosorb ro-18 (5 μm) (250 x 4 mm) chromatography column with uv detection at 280 nm using a mobile phase composed by a non-gasified mixture of methanol distilled water (1:1) with 1.1 g of 1-sodium octane-sulphonate by liter adjusted to ph 3,0 with phosphoric acid at a flow speed of 1.0 ml/min. analytical method was linear, accuracy, specific and exact in the interval of study concentrations.
Validación del método de valoración biológica de gonadotrofina coriónica humana
Lagarto Parra,Alicia; García Pe?a,Caridad; Gabilondo Ramírez,Tatiana; Triana Manso,Osmaida;
Revista Cubana de Farmacia , 2012,
Abstract: introduction: a number of biological tests for quality control used in the center for drug research and development should be validated. biological potency test of human chorionic gonadotropin is one of them. objective: to evaluate the performance of the human chorionic gonadotropin biological potency test. methods: the accuracy, precision and specificity were evaluated as validation parameters according to the 41-2007 regulation of the center for the state control of drug quality (cedmed) for analysis method validation. results: in the accuracy test, no significant differences were observed between the uterus weight values from tested sample and the reference material at the 3 tested doses. variation coefficients were less than 50 % in the repeatability test. there were no significant differences between the precision values of two different analysts at different times. the specificity test showed that excipients or auxiliary substances in the formulation did not interfere with the results of the biologic potency test of the final product. conclusions: the validated biological method showed good accuracy, precision and specificity in the range of studied concentrations, all of which proved its quality, so it has added value.
Validación del método de determinación de efecto anestésico local
Lagarto Parra,Alicia; Torres Amaro,Leonid; Carrillo Domínguez,Carmen; Gabilondo Ramírez,Tatiana;
Revista Cubana de Farmacia , 2012,
Abstract: introduction: a biological test is used to measure local anesthesia time of a drug or an active principle under research. objective: to validate the measuring method of local anesthesia time for the evaluation of generic drug with this pharmacological action. methods: accuracy, precision, robustness, linearity, parallelism and specificity were evaluated according to the methodology described in 41-2007 regulation of the center for the state control of drug quality (cedmed). results: in the accuracy test, no significant differences were observed between the results of tested sample and the reference material at the 3 tested doses. variation coefficients was less than 50 % in the repeatability test. there were no significant differences between the precision values of two different analysts at different times and in three different batches. the specificity test showed that excipients or auxiliary substances in the formulation did not interfere with the evaluation of the product. the method was linear in a 50-120 % range of concentrations, with acceptable accuracy and precision, and parallelism. the robustness test yielded no differences in the results obtained after changing various parameters. conclusions: biological method proved to be accurate, precise, specific, linear and robust.
Development and Validation of Infrared Spectroscopy Method for the Determination of Darunavir in Tablets#
Physical Chemistry , 2013, DOI: 10.5923/j.pc.20130301.01
Abstract: Darunavir is a protease inhibitor used in the treatment of HIV infection. It is a pillar of therapy cocktail for patients with this virus. This work proposed the development and validation of an infrared spectroscopy method for the determination of darunavir in tablets. The method was completely validated according to the International Conference on Harmonization guidelines, showing accuracy, precision, selectivity, robustness and linearity. It was linear over the concentration range of 1.5-3.5 mg with correlation coefficients greater than 0.9991 and limits of detection and quantification of 0.12 and 0.36 mg, respectively. The validated method is very useful to the routine quality control of darunavir, since it does not use polluting reagents, it is simple and has low-cost.
Comparative Analysis and Validation Methodologies of GC and HPLC for Analysis of Cholesterol in Meat Products  [PDF]
Gisely Luzia Stroher, Angela Claudia Rodrigues, Lucia Felicidade Dias, Mayka Reghiany Pedr?o, Luana Nascimento de Paula, Jesui Vergilio Visentainer, Nilson Evelazio de Souza
American Journal of Analytical Chemistry (AJAC) , 2012, DOI: 10.4236/ajac.2012.34042
Abstract: This study validated different extraction methodologies and compared the quantification of cholesterol by gas chromatography (GC) and high performance liquid chromatography (HPLC) in mg per 100 g of Italian-type salami and traditional bologna. The GC method used was direct saponification of the samples without derivatizations and the HPLC method was used to extract of the lipid samples. The GC limits of detection and quantification obtained for cholesterol were, respectively, 0.001 and 0.003 mg.g–1. The HPLC values were 0.005 mg.g–1 and 0.016 mg.g–1. The GC recovery rate was 97.10 ± 0.13 and that of HPLC was 93.33 ± 0.22. Comparison of the cholesterol quantity found using the two chromatographic techniques shows that both are capable of quantifying cholesterol in the foods. With regard to costs, analysis time, the cost/benefit relationship was better with gas chromatography than that obtained with high performance liquid chromatography.
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