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Registros recuperados: 6
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A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations BJPS
Pandey,Saurabh; Pandey,Preeti; Mishra,Durgesh; Singh,Umesh Kumar.
A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 µgmL-1), LOQ (0.13-0.14 µgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: High performance liquid chromatography/qualitative analysis; High performance liquid chromatography/method development; Pantoprazole/forced degradation.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100019
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Copaiba oleoresin: evaluation of the presence of polycyclic aromatic hydrocarbons (PAHs) BJPS
Silva,Wilson Gomes da; Cortesi,Nicoletta; Fusari,Paola.
The copaiba oleoresin extracted by perforating the tree-trunk found in the Amazonian forest has been used by the native indigenous communities to treat several diseases and also as fuel for lighting and for the motorboats plying the region's rivers. Currently, the oleoresin is mostly employed as a traditional remedy, mainly for the treatment of tonsillitis and as an anti-inflammatory and healing agent in oil and capsule forms, and is also used in several industry sectors. Due to its use in oral form, especially as a traditional remedy, an analysis of the presence of polycyclic aromatic hydrocarbons (PAHs) as contaminants in the oleoresin was performed. PAHs are substances formed by two or more benzoic rings and found in the atmosphere as a residue from...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Copaiba/oil; Copaiba/qualitative analysis; Polycyclic aromatic hydrocarbons; High performance liquid chromatography/qualitative analysis; Amazônia/traditional remedy.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000300025
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Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension BJPS
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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Development and validation of an HPLC method for stability evaluation of nystatin BJPS
Cione,Ana Paola Prata; Liberale,Márcio José; Silva,Paulo Marcos da.
A liquid chromatography method for evaluating the stability of Nystatin (Nys) in an ointment was developed and validated, since the traditional pharmacopeial microbiological methods are unable to indicate stability. The stress experiments showed that Nys was found to significantly degrade in alkaline and acidic conditions and also under oxidative stress. Lower levels of degradation were detected under heat and with the sample exposed to Xenon light. Resolutions higher than 2 for Nys and degradation products (DP) chromatographic peaks were achieved by using an Inerstil ODS-3 column, isocratic elution with methanol:water and UV detection at 305 nm. The system was found to be linear over a range of 102 to 310 IU mL-1 and proved precise, since the RSD(%) was...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Nystatin/stability analysis; Forced degradation/stress; High performance liquid chromatography/qualitative analysis.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200018
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Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets BJPS
Nogueira,Fernando Henrique Andrade; Reis,Naialy Fernandes Araújo; Chellini,Paula Rocha; César,Isabela da Costa; Pianetti,Gerson Antônio.
The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 µm particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Artesunate/determination; Mefloquine hydrochloride/determination; High performance liquid chromatography/qualitative analysis; Fixed-dose combination tablets/qualitative analysis.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400024
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Validation of a liquid chromatographic method for determination of related substances in a candidate certified reference material of captopril BJPS
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
Registros recuperados: 6
Primeira ... 1 ... Última
 

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