Using total error concept for the validation of a liquid chromatography–tandem mass spectrometry method for the determination of budesonide epimers in human plasma

Streel, Bruno; Cahay, Bernard; Klinkenberg, Régis

doi:10.1016/j.jchromb.2009.02.004

Cited by 14 publications

(12 citation statements)

References 19 publications

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“…The study by Borges et al [15] accomplished ionization with an atmospheric pressure photoionization interface in positive mode while Lu et al [16] used an electrospray ionization interface and monitored the acetate adduct in negative mode. We were not successful in monitoring the acetate adduct with our equipment even though this has been preferred by several authors [11,13,14,16].…”

Section: Discussionmentioning

confidence: 99%

“…A number of bioanalytical methods have been described for determination of budesonide in biological media [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

“…Early studies of budesonide pharmacokinetics utilized liquid chromatography in combination with administration of 3 H-labeled budesonide and off-line radioactive detection [8,23]. Combined liquid chromatography-tandem mass spectrometry (LC-MS/MS) is, however, the preferred technique for determination of budesonide in human [9][10][11][12][13][14][15][16], dog [17,18], and pig [19] plasma, as well as in other biological matrices [20,21] ever since the advent of this technology. The first published bioanalytical method for determination of budesonide in human plasma using LC-MS was already in 1992 and used solid-phase extraction, straight phase chromatography, thermospray ionization, and reported a measuring range still comparable with more recent publications [9].…”

Section: Introductionmentioning

confidence: 99%

“…liquid-liquid [15] or solid-phase extraction [14], and chromatography has been performed with reversed-phase columns. Most methods have used monitoring of negative ions in selected reaction monitoring mode and interfaces have been using atmospheric pressure electrospray, chemical or photo ionization.…”

Section: Introductionmentioning

confidence: 99%

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Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC–MS/MS

Nilsson¹,

Andersson²,

Beck³

2014

Journal of Chromatography B

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Section: Discussionmentioning

confidence: 99%

“…A number of bioanalytical methods have been described for determination of budesonide in biological media [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC–MS/MS

Nilsson¹,

Andersson²,

Beck³

2014

Journal of Chromatography B

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“…Elles concernent aussi bien le dosage de 5 antibiotiques [6], le dosage d'antirétro-viraux par HPLC/DAD [7] que le dosage de neuf antiépilep-tiques sur 100 μL de plasma [8], la cyclosporine sur 100 μL de plasma [9], du budénoside avec une limite de quantification de 50 pg/mL par LC/MS [10] ; le dosage de la simvastatine et de l'atorvastatine [11], du fentanyl avec une limite de quantification de 50 pg/mL par le couplage LC/MS/MS [12]. Le dosage du vigabatrin a également pu être réalisé par électrophorèse capillaire équipée d'un détecteur fluorescent [13].…”

Section: Applicationsunclassified

Extraction en phase solide (SPE) : théorie et applications

Humbert

2010

Ann Toxicol Anal

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Résumé -L'extraction en phase solide (SPE) est devenue depuis quelques années une technique de préparation d'échantillons de plus en plus utilisée en toxicologie analytique. Son principe de base est analogue à celui de la chromatographie de partage. Depuis son apparition de nombreuses phases stationnaires ont été développées par les industriels, permettant des extractions de plus en plus ciblées, ou bien adaptées pour l'extraction d'un grand nombre de substances de natures chimiques variées : pour une recherche large de xénobiotiques en milieu hospitalier pour des patients admis aux urgences ou en médecine légale dans les recherches des causes de la mort. De par la diversité des phases stationnaires elle permet l'extraction de composés polaires difficilement extractibles auparavant par les phases organiques. L'extraction se déroule généralement en quatre étapes : le conditionnement de la phase stationnaire, le chargement de l'échantillon, le(s) lavage(s) de la cartouche et enfin l'élution. La maîtrise de ce pré-analytique permet des facteurs de pré-concentration de(s) analyte(s) à rechercher ou à doser qui peut abaisser la limite de détection d'une méthode. Les larges gammes commercialisées par les industriels sont adaptées à des extractions ponctuelles de volumes très variés (de quelques dizaines de microlitres à plusieurs millilitres voire litres) mais aussi à l'extraction de grandes séries grâce à des plaques de 96 puits. C'est aussi une technique qui a l'avantage d'être automatisable. De très nombreuses mé-thodes analytiques ont été développées sur les matrices biologiques habituelles : le sérum, le plasma ou les urines mais également dans des matrices plus complexes comme les cheveux ou le méconium. Mots clés : Extraction, phase stationnaire, matrices biologiquesAbstract -Solid phase extraction (SPE) has become, in recent years, a technique for sample preparation increasingly used in analytical toxicology. Its basic principle is similar to that of partition chromatography. Since its appearance, many stationary phases have been developed by industry for more targeted extractions or adapted for the extraction of a large number of chemical substances of various kinds for a wide search for xenobiotics in hospital for patients admitted to the emergency ward, or forensic research into the causes of death. Because of the variety of stationary phases it allows the extraction of polar compounds from previously difficult to extract organic phases. The extraction is generally conducted in four steps: conditioning of the stationary phase, loading of the sample, washing(s) of the cartridge and finally, elution. Control of this pre-analytical stage allows factors of pre-concentration of the analyte(s) to search for or to be determined which can lower the limit of detection of a method. The wide ranges marketed by the industry are suitable for specific extraction of very varied volumes (a few tens of microliters up to several mL or liters) but also for extraction of large sets with plates of 96 wells. It is also a techniq...

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Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations

King

Pietrasiewicz

et al. 2020

Biomedical Chromatography

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Bioanalysis, a key supporting function for generating data for pre-clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community.

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Using total error concept for the validation of a liquid chromatography–tandem mass spectrometry method for the determination of budesonide epimers in human plasma

Cited by 14 publications

References 19 publications

Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC–MS/MS

Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC–MS/MS

Extraction en phase solide (SPE) : théorie et applications

Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations

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