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| Rubim,Alexandre Machado; Rubenick,Jaqueline Bandeira; Gregolin,Eduarda; Laporta,Luciane Varini; Leitenberg,Rosimar; Rolim,Clarice Madalena Bueno. |
| abstract Amiodarone HCl is an antiarrhythmic agent, which has low aqueous solubility and presents absorption problems. This study aimed to develop inclusion complexes containing hydrophilic carriers PEG 1500, 4000 and 6000 by fusion and kneading methods in order to evaluate the increase in solubility and dissolution rate of amiodarone HCl. The solid dispersion and physical mixtures were characterized by X-ray diffraction, FT-IR spectra, water solubility and dissolution profiles. Both methods and carriers increased the solubility of drug, however PEG 6000 enhanced the drug solubility in solid dispersion better than other carriers. Different media were evaluated for the solubility study, including distilled water, acid buffer pH 1.2, acetate buffer pH 4.5... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Amiodarone hydrochloride/dissolution profile; Amiodarone hydrochloride/solid dispersion; Hydrophilic polymer.. |
| Ano: 2015 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400957 |
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| Rubim,Alexandre Machado; Rubenick,Jaqueline Bandeira; Laporta,Luciane Varini; Rolim,Clarice Madalena Bueno. |
| The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Dissolution method/development; Dissolution method/validation; Diclofenac potassium/release in oral suspensions; Oral suspension/quality control; High performance liquid chromatography/qualitative analysis. |
| Ano: 2014 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200423 |
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| Nogueira,Raquel; Rego,Eliane Cristina Pires do; Sousa,Marcus Vinicius Barreto; Wollinger,Wagner; Silva,Thaís Elias da; Moreira,Gabriela Fernandes; Barin,Juliano Smanioto; Laporta,Luciane Varini; Mesko,Márcia Foster; Bittencourt,Celso Figueiredo; Rodrigues,Janaína Marques; Cunha,Valnei Smarçaro da. |
| This paper describes the studies performed with the candidate Certified Reference Material (CRM) of captopril, the first CRM of an active pharmaceutical ingredient (API) in Brazil, including determination of impurities (organic, inorganic and volatiles), homogeneity testing, short- and long-term stability studies, calculation of captopril content using the mass balance approach, and estimation of the associated measurement uncertainty. |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Captopril/qualitative analysis; Medicines/Certified Reference Standards; Medicines/analytical quality control; High Pressure Liquid Chromatography (HPLC)/qualitative analysis; Medicines/contamination. |
| Ano: 2011 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200015 |
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| Nogueira,Raquel; Wollinger,Wagner; Silva,Thaís Elias da; Oliveira,Leonardo Mesquita de; Rego,Eliane Cristina Pires do; Moreira,Gabriela Fernandes; Barin,Juliano Smanioto; Laporta,Luciane Varini; Mesko,Márcia Foster; Bittencourt,Celso Figueiredo; Rodrigues,Janaína Marques; Cunha,Valnei Smarçaro da. |
| This paper describes the validation of a reversed-phase high performance liquid chromatography method (RP-HPLC) with diode array detection (DAD) for determination of related substances (impurities from organic synthesis and degradation products) of captopril according to the Brazilian Pharmacopeia IV. The aim of this study was to guarantee the method accuracy for quantification of related substances, an essential requisite to determine, using the mass balance approach, the captopril content in the first Brazilian certified reference material (CRM) of an active pharmaceutical ingredient (API), developed by Inmetro. The captopril instability in solution is discussed and the captopril content determined by mass balance is compared to the results from... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Captopril/qualitative analysis; Medicines/analysis; Medicines/method validation; Medicines/analytical quality control; High performance liquid chromatography/qualitative analysis; Medicines/contamination; Captopril/certified reference standards. |
| Ano: 2011 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200016 |
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| 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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