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| 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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| 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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| 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,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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