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| Queiroz,Kelly Marques; Silva,Maria-Luiza Martins; Prado,Nathália Duque; Lima,Paulo Marcelo Andrade; Diniz,Rosiane Dias Lopes; César,Isabela Costa; Pianetti,Gerson Antônio; Santos,Daniel Assis. |
| The development of a specific agar diffusion bioassay for the quantitative determination of fluconazole formulated in capsules was carried out using a strain of Candida albicans ATCC 18804 as the test organism. A prospective validation of the method showed adequate linearity (r²=0.9995), precision (R.S.D. = 4.0% for intra-day and 4.5% for inter-day precision) and accuracy (mean recovery = 102.9%). High performance liquid chromatography was chosen as a comparison method for the fluconazole determination. The contents of fluconazole determined by both methods, for four capsule samples, showed a strong correlation, confirmed by Pearson's correlation coefficient value (r = 0.9884). The bioassay is a suitable method for both research and pharmaceutical industry... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Fluconazole/quantitative determination; Microbiological assay/agar diffusion; High performance liquid chromatography. |
| Ano: 2009 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000400012 |
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| 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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| Souza,Mateus Araújo Castro e; Pereira,Carlos Eduardo de Oliveira; Nogueira,Fernando Henrique Andrade; Pianetti,Gerson Antônio. |
| ABSTRACT A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust,... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Diltiazem hydrochloride/compounded capsules; Diltiazem hydrochloride/tablets; High performance liquid chromatography /method validation; Stability indicating method. |
| Ano: 2017 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000300602 |
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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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| Silva,Pedro Henrique Reis da; Enéas,Paula Cristina Rezende; Fernandes,Christian; Pianetti,Gerson Antônio. |
| ABSTRACT Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high-performance liquid chromatographic (HPLC) method has been described in the literature for the determination of prednisone in capsules until now. Thus, an HPLC method was developed using a C18 (250x4.0, 5 µm) column, with methanol:water (70:30) as mobile phase at a flow rate of 1 mL/min and detection at 240 nm. The developed method was validated following current Brazilian legislation. Additionally, linearity was assessed by evaluating the assumptions of normality, homoscedasticity, and independency of residuals, and the fit to the linear model. The method showed linearity (r2>0.99) over the range of 14.0-26.0 µg/mL, selectivity, precision... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Prednisone; Capsules; High performance liquid chromatography/validation; Linearity assessment.. |
| Ano: 2017 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000200624 |
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| Enéas,Paula Cristina Rezende; Oliveira,Renata Barbosa de; Pianetti,Gerson Antônio. |
| Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Oxcarbazepine/quantitative analysis; Anticonvulsants/quantitative analysis; UV spectrophotometric/method validation; Capsules/dissolution. |
| Ano: 2010 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200013 |
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| Costa,André Lima de Oliveira; Enéas,Paula Cristina Rezende; Miranda,Tiago Assis; Mingoti,Sueli Aparecida; Soares,Cristina Duarte Vianna; Pianetti,Gerson Antônio. |
| Mycophenolate mofetil (MMF) and mycophenolate sodium (MPS) are an ester and a salt of mycophenolic acid. They have different kinetic in vivo characteristics due to differences in molecular structures, physicochemical properties and formulations administered. In this study, dissolution profiles of reference products were tested in different media to evaluate the effect of pH, kinetic dissolution and the best statistical model that can be used to predict the release of both drugs. The drug release was determined by using a validated ultraviolet spectrophotometry method, λ 250 nm. The method showed to be selective, linear, precise and accurate for MMF in 0.1 M HCl and MPS in sodium phosphate buffer pH 6.8. Dissolution kinetics models of zero order, first... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Mycophenolate sodium; Mycophenolate mofetil; Dissolution profiles; Weibull kinetics. |
| Ano: 2013 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200013 |
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