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Compatibility and stability of valsartan in a solid pharmaceutical formulation BJPS
Júlio,Tamíris Amanda; Zâmara,Igor Fernando; Garcia,Jerusa Simone; Trevisan,Marcello Garcia.
Valsartan (VAL) is a highly selective blocker of the angiotensin II receptor that has been widely used in the treatment of hypertension. Active pharmaceutical ingredient compatibility with excipients (crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose and titanium dioxide) is usually evaluated in solid pharmaceutical development. Compatibility and stability can be evaluated by liquid chromatography. Studies were performed using binary mixtures of 1:1 (w/w) VAL/excipient; samples were stored under accelerated stability test conditions (40 ºC at 75% relative humidity). The results indicate that VAL is incompatible with crospovidone and hypromellose, which reduced the VAL content and gave rise to new peaks in the chromatogram due to...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Valsartan/compatibility; Valsartan/stability; Hypertension/treatment; Differential Scanning Calorimetry/drug analysis; High performance liquid chromatography/quantitative analysis; Pharmaceutical formulations/quantitative analysis...
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400003
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Development and validation of a HPLC analytical assay method for efavirenz tablets: a medicine for HIV infections BJPS
Viana,Osnir de Sá; Medeiros,Flávia Patrícia Morais; Grangeiro-Júnior,Severino; Albuquerque,Miracy Muniz; Soares,Mônica Felts La Roca; Soares-Sobrinho,José Lamartine; Alves,Lariza Darlene Santos; Rolim,Larissa Araújo; Silva,Keyla Emanuelle Ramos da; Rolim-Neto,Pedro José.
Efavirenz is a reverse transcriptase non analog nucleoside inhibitor used to treat HIV infections. A simple assay method by high performance liquid chromatography was developed and validated for efavirenz tablets. The physical chemical characteristics of efavirenz were investigated to developing the method. The method was validated observing the parameters described in USP 29. Analyses were performed by an ultraviolet detector at a 252 nm wavelength, on a reverse-phase column (C18, 250 mm x 3.9 mm, 10 μm), using an isocratic mobile phase containing acetonitrile/water/orthophosphoric acid (70:30:0.1). The validation parameters used were: selectivity, linearity, precision, accuracy, robustness, detection and quantification limits, and all resulting data were...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Efavirenz/tablet assay; High performance liquid chromatography/quantitative analysis.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000100012
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Development and validation of a rapid high performance liquid chromatography - photodiode array detection method for estimation of a bioactive compound wedelolactone in extracts of Eclipta alba BJPS
Kumar,Satyanshu; Dhanani,Tushar.
Following optimization of extraction, separation and analytical conditions, a rapid, sensitive and simple reverse-phase high performance liquid chromatography-photo diode array (HPLC-PDA) method has been developed for the identification and quantification of wedelolactone in different extracts of Eclipta alba. The separation of wedelolactone was achieved on a C18 column using the solvent system consisting of a mixture of methanol: water: acetic acid (95: 5: 0.04) as a mobile phase in isocratic elution mode followed by photo diode array detection at 352 nm. The developed method was validated as per the guidelines of the International Conference on Harmonization (ICH). Calibration curve presented good linear regression (r²>0.998) within the test range and...
Tipo: Info:eu-repo/semantics/article Palavras-chave: High performance liquid chromatography/quantitative analysis; High performance liquid chromatography/photo diode array; High performance liquid chromatography/method validation; Eclipta alba/extracts; Eclipta alba/analysis; Wedelolactone/quantification.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100007
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Development and validation of an HPLC method for the determination of fluorouracil in polymeric nanoparticles BJPS
Mattos,Ana Cristina de; Khalil,Najeh Maissar; Mainardes,Rubiana Mara.
The objective of this work was to develop and validate a rapid high performance liquid chromatography (HPLC) method for the quantitative analysis of fluorouracil (5-FU) in polymeric nanoparticles. Chromatographic analyses were performed on an RP C18 column with a mobile phase consisting of acetonitrile and water (10:90, v/v) at a flow rate of 1 mL/min. The 5-FU was detected and quantitated using a photodiode array detector at a wavelength of 265 nm. The method was shown to be specific and linear in the range of 0.1-10 µg/mL (r = 0.9997). The precision (intra- and inter-day) was demonstrated because the maximum relative standard deviation was 3.51%. The method is robust relative to changes in flow rate, column and temperature. The limits of detection and...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Fluorouracil/determination; Nanoparticles; High performance liquid chromatography/quantitative analysis; High performance liquid chromatography/method validation.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100013
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Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions BJPS
Urban,Maria Cristina Cocenza; Mainardes,Rubiana Mara; Gremião,Maria Palmira Daflon.
A simple, rapid, accurate and sensitive method was developed for quantitative analysis of dexamethasone acetate in microemulsions using high performance liquid chromatography (HPLC) with UV detection. The chromatography parameters were stainless steel Lichrospher 100 RP-18 column (250 mm x 4 mm i.d., 5 μm particle size), at 30 ± 2 ºC. The isocratic mobile phase was methanol:water (65:35; v/v) at a flow rate of at 1.0 mL.min-1. The determinations were performed using UV-Vis detector set at 239 nm. Samples were prepared with methanol and the volume injected was 20 μL. The analytical curve was linear (r² 0.9995) over a wide concentration range (2.0-30.0 μg.mL-1). The presence of components of the microemulsion did not interfere in the results of the analysis....
Tipo: Info:eu-repo/semantics/article Palavras-chave: Dexamethasone acetate/determination; Microemulsions/quantitative analysis; High performance liquid chromatography/quantitative analysis; Analytical method/validation.
Ano: 2009 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000100010
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Development of alternative methods for the determination of raloxifene hydrochloride in tablet dosage form BJPS
Salazar,Fernanda Rodrigues; Codevilla,Cristiane Franco; Meneghini,Leonardo; Bergold,Ana Maria.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Raloxifene/determination in tablets; High performance liquid chromatography/quantitative analysis; UV spectrophotometric method/quantitative analysis; Micellar capillary electrophoresis/ quantitative analysis; Stability-indicating methods.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000200349
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Prevalence of hemoglobinopathies in school children: the importance of using confirmatory methods BJPS
Tavares,Cristiane Fernandes de Freitas; Guimarães,Jacqueline da Silva; Souza,Ana Maria de.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Hemoglobinopathy; Hemoglobin electrophoresis; High performance liquid chromatography/quantitative analysis; Polymerase chain reaction.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000200361
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Quantification and stress degradation studies of cefepime/tazobactam in dry injection form by an RP-HPLC method BJPS
Kommana,Ramakrishna; Kannabattula,Gouthami; Gurrala,Sunitha; Yeradesi,Venkat Raj; Durga,Panikumar Anumolu.
A simple, specific, precise, accurate, linear, rapid, economic and validated stability indicating an RP-HPLC method for the simultaneous quantification of cefepime and tazobactam in a dry injection dosage form has been developed. Separation was performed on a 5 µm ACE C18column with phosphate buffer, pH adjusted to 4.5 with phosphoric acid: methanol (70:30) at a flow rate of 1 mL/min and at a temperature of 25 °C. Regression analysis showed linearity at a detector wavelength of 290 nm in the range of 200-600 μg/mL for cefepime and 25-75 μg/mL for tazobactam. All of the analytes were adequately resolved with acceptable tailing. The percentage content found for cefepime was 99.98% and of tazobactam was 99.49% in the parenteral formulation. The method was...
Tipo: Info:eu-repo/semantics/article Palavras-chave: High performance liquid chromatography/quantitative analysis; Cefepime/quantificação; Tazobactam/quantificação; Dry injection formulation/quantitative analysis; Pharmaceutical formulations/degradation studies.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000400895
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Quantitation of artemether in pharmaceutical raw material and injections by high performance liquid chromatography BJPS
César,Isabela da Costa; Pianetti,Gerson Antônio.
The quantitation of artemether in both pharmaceutical raw material and injections was carried out by high performance liquid chromatography (HPLC) with ultraviolet detection. A Zorbax C18 column (150 x 4.6 mm; 5 μm), at 30 °C, and a mobile phase composed of acetonitrile and water (70:30), at a flow rate of 1ml/min, were used. The detection wavelength was 216 nm and the injection volume was 20 μL. The method proved to be linear (r²=0.9999), precise (RSD < 20% for intra-day and inter-day precision), accurate and selective regarding possible impurities and excipients of the samples. The detection and quantitation limits were 8 μg/mL and 25 μg/mL, respectively. The artemether content obtained in the raw material analysis was 99.26% and in the injections,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Artemether/quantitation; High performance liquid chromatography/quantitative analysis; Antimalarials.
Ano: 2009 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000400018
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Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography BJPS
Silva,Viviane Benevenuti; Galdos,Angel Arturo Gaona; Mothe,Cintia Maria Alves; Pallastrelli,Michele Bacchi; Prado,Maria Segunda Aurora; Singh,Anil Kumar; Kedor-Hackmann,Erika Rosa Maria; Santoro,Maria Inês Rocha Miritello.
A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Coated tablets/quantitative analysis; High performance liquid chromatography/quantitative analysis; Ethinyl estradiol/quantitative determination; Drospirenone/quantitative determination; Fluorescence detection; UV detection.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000300013
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Spectrophotometric and HPLC determination of deflazacort in pharmaceutical dosage forms BJPS
Scremin,Amarilis; Piazzon,Monika; Silva,Marcos Antonio Segatto; Kuminek,Gislaine; Correa,Giane Márcia; Paulino,Niraldo; Cardoso,Simone Gonçalves.
Deflazacort (DFZ) is a glucocorticoid used as an anti-inflammatory and immunosuppressant drug. No official methods are available for DFZ determination in pharmaceutical formulations. The objective of this study was to develop, validate and compare spectrophotometric (UV and colorimetric) and high-performance liquid chromatography (HPLC) methods, for the quantitative determination of DFZ in tablets and oral suspension. For the UV method, ethanol was used as the solvent, with detection at 244 nm. The colorimetric method was based on the redox reaction with blue tetrazolium in alkaline medium, with detection at 524 nm. The method by HPLC was carried out using a C18 column, mobile phase consisting of acetonitrile:water (80:20, v/v) with a flow rate of 1.0 mL...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Deflazacort/quantitative determination; High performance liquid chromatography/quantitative analysis; Spectrophotometry/quantitative analysis; Medicines/quantitative analysis.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200015
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Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products BJPS
Sevim,Serpil; Erk,Nevin.
abstract The antiparkinson agent pramipexole dihydrochloride monohydrate was quantified in pharmaceutical products by high performance liquid chromatography (HPLC) and derivative spectrophotometry. The first method was based on HPLC using tamsulosin HCl as an internal standard. In this method, chromatographic separation was achieved using a LiChrospher 60 RP column at 25°C, with a flow rate of 1.0 mL/min at 263 nm. The eluent comprised 0.01 mol/L ammonium acetate (pH 4.4) and acetonitrile (35:65 by volume). The linearity range was found to be 10.0-30.0 µg/mL with a mean recovery of 100.5 ± 1.10. The limit of detection (8 ng/mL) and limit of quantification (50 ng/mL) were calculated. In the second method, the first derivative spectrophotometric technique...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Antiparkinson agent/determinação; Pramipexole dihydrochloride monohydrate; Pharmaceutical product/quality control; High performance liquid chromatography/quantitative analysis; Derivative spectrophotometry/quantitative analysis..
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400879
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Validation of high performance liquid chromatography method for determination of meloxicam loaded PEGylated nanocapsules BJPS
Ianiski,Francine Rodrigues; Laporta,Luciane Varini; Rubim,Alexandre Machado; Luchese,Cristiane.
abstract A method to ensure that an analytical method will produce reliable and interpretable information about the sample must first be validated, making sure that the results can be trusted and traced. In this study, we propose to validate an analytical high performance liquid chromatography (HPLC) method for the quantitation of meloxicam loaded PEGylated nanocapsules(M-PEGNC). We performed a validation study, evaluated parameters including specificity, linearity, quantification limit, detection limit, accuracy, precision and robustness. PEGylated nanocapsules were prepared by interfacial deposition of preformed polymer, and the particle size, polydispersity index, zeta potential, pH value and encapsulation efficiency were characterized. The proposed...
Tipo: Info:eu-repo/semantics/article Palavras-chave: High performance liquid chromatography/quantitative analysis; Meloxicam/determination; PEGylated nanocapsules/quality control; Nanoparticles; Poly(ethylene glycol)..
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400823
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