Uncertainty budget for final assay of a pharmaceutical product based on RP–HPLC

Anglov, Thomas; Byrialsen, Kirsten; Carstensen, Jan Karkov; Christensen, Finn Kjær; Christensen, Steen; Madsen, Birger Stjernholm; Sørensen, Else; Sørensen, Jeanett Norrbohm; Toftegård, Karin; Winther, Henrik; Heydorn, Κ.

doi:10.1007/s00769-003-0621-0

Cited by 23 publications

(8 citation statements)

References 3 publications

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“…Anglov and collaborators [13] performed similar studies concerning reverse phase high performance liquid chromatography (RP-HPLC). In this study, they evaluated the uncertainty contributions of repeatability of peak area, dilutions factors, reference materials and sampling.…”

Section: Uncertainty In Pharmaceutical Analysismentioning

confidence: 99%

“…The uncertainty on the results may arise from many possible sources, including sampling, matrix effects and interferences, environmental conditions, uncertainties of mass and volumetric equipment, uncertainties of spectrophotometric and chromatographic equipment, uncertainties of biological and microbiological responses, purity of reagents and chemical reference substances, method validation and random variability [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] .…”

Section: Introductionmentioning

confidence: 99%

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Measurement uncertainty in pharmaceutical analysis and its application

Traple

Saviano

Francisco

et al. 2014

Journal of Pharmaceutical Analysis

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The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.

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Section: Uncertainty In Pharmaceutical Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Measurement uncertainty in pharmaceutical analysis and its application

Traple

Saviano

Francisco

et al. 2014

Journal of Pharmaceutical Analysis

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show abstract

“…The main sources of uncertainty should be considered in the final uncertainty estimation, including sampling (Wunderli, 2003), matrix effects and interferences, environmental conditions (Leito et al, 2002;Lourenço et al, 2012), uncertainties of mass and volumetric equipment, uncertainties of spectrophoto-metric (Sooväli et al, 2006;Hsu and Chen, 2010) and chromatographic equipment (Anglov et al, 2003;Lourenço, 2012), uncertainties of biological and microbiological responses (Niemi and Miemelã, 2001;Lourenço, 2012), purity of reagents and chemical reference substances (Weitzel, 2012), method validation (Brüggemann and Wennrich, 2002) and random variability (Chui et al, 2002).…”

Section: Introductionmentioning

confidence: 99%

An alternative capillary electrophoresis method for the quantification of caspofungin in lyophilisate powder and its measurement uncertainty

Daniela¹,

Pinto²

2014

Afr. J. Pharm. Pharmacol.

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Recently, the use of capillary electrophoresis (CE) methods in pharmaceutical practice has gradually increased. Moreover, measurement uncertainty has been used to guarantee the traceability and the reliability of analytical results obtained. The aim of this work was to develop and validate a CE method for the quantification of caspofungin in lyophilised powder for injection, as well as to study the main sources of uncertainty associated with the method proposed and establish a procedure to estimate uncertainty in routine analysis. The results obtained during the validation procedure were statistically evaluated and demonstrate the specificity, robustness, linearity (r = 0.9999; y= 7.9014x-0.0107, concentration range: 20 to 300 g/ml), precision (repeatability, RSD: 0.40%; intermediate precision, RSD: 0.54%) and accuracy (recovery range: 95.80 to 100.45%). Without using internal standard correction, almost all uncertainty is associated to repeatability of sample and standard peak areas (more than 90%). On the other hand, using internal standard reduced variability significantly. The results allow us to affirm that EC method is suitable for analysis of caspofungin and it may be applied in routine quality control laboratories. In addition, this study confirmed that the equations proposed in the paper may be used for the measurement of uncertainty estimation in routine analysis.

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“…EURACHEM/CITAC, 2012). A incerteza de medição de um resultado pode surgir de muitas fontes, incluindo fatores como amostragem, efeitos da matriz e interferentes, condições ambientais, incerteza proveniente de balanças e equipamentos volumétricos, incerteza proveniente de equipamentos espectrofotométricos e cromatográficos, incertezas provenientes da resposta biológica e microbiológica, pureza de reagentes e substâncias químicas de referência, validação de métodos e erros aleatórios (NIEMI e NIEMELÃ, 2001;BRÜGGEMANN e WENNRICH, 2002;CHUI et al, 2002;LEITO et al, 2002;ANGLOV et al, 2003;WUNDERLI, 2003;LOURENÇO et al, 2004, LOURENÇO et al, 2005, SOOVÄLI et al, 2006LOURENÇO et al, 2007, HSU e CHEN, 2010LOURENÇO, 2012;LOURENÇO et al, 2012, WEITZEL, 2012LOURENÇO, 2013;SAVIANO e LOURENÇO, 2013;GHISLENI et al, 2014; OSTRONOFF e LOURENÇO, 2015).…”

Section: Introductionunclassified

Desenvolvimento de métodos microbiológicos rápidos (MMRs) para avaliação da potência de agentes antimicrobianos e suas incertezas de medição

Saviano¹

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Agradeço à Deus pela vida e toda proteção, iluminação e orientação no meu caminho que possibilitou desenvolver meu aprendizado e capacidades na elaboração deste trabalho. Aos meus pais Nelson (em memória) e Núbia por todo amor, fé, paciência, confiança, compreensão e humildade e por todas as coisas boas e gratificantes que me ensinaram na minha vida. Ao meu irmão Nelson e minha cunhada Cristina, pelo incentivo, apoio e força para atingir mais esse objetivo na minha vida profissional. Ao professor Felipe Rebello Lourenço que acreditou em mim, oferecendo novamente a oportunidade da sua orientação, sempre ensinando e esclarecendo minhas dúvidas de forma simples, paciente e principalmente humilde. A professora Irene Satiko Kikuchi, por seus conselhos sábios e ensinamentos valiosos, que incentivaram meu crescimento pessoal e profissional na área acadêmica. As professoras Terezinha de Jesus Andreoli Pinto e Telma Mary Kaneko, pelo exemplo na área da docência farmacêutica. O presente trabalho foi realizado com apoio da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES)-Código de Financiamento 001 e também através do processo nº 2016/04100-8, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). Aos funcionários do Confar, Cleide, Diane, Daniela, Elisabete e Rogério, que foram muito prestativos no auxílio dos ensaios que precisei realizar. A todos professores, funcionários, colegas do laboratório e da pós-graduação da USP, pela amizade, apoio e que de alguma forma contribuíram para a realização deste trabalho. Meus sinceros agradecimentos.

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Uncertainty budget for final assay of a pharmaceutical product based on RP–HPLC

Cited by 23 publications

References 3 publications

Measurement uncertainty in pharmaceutical analysis and its application

Measurement uncertainty in pharmaceutical analysis and its application

An alternative capillary electrophoresis method for the quantification of caspofungin in lyophilisate powder and its measurement uncertainty

Desenvolvimento de métodos microbiológicos rápidos (MMRs) para avaliação da potência de agentes antimicrobianos e suas incertezas de medição

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