Quality Assurance, Quality Control and Method Validation in Chromatographic Applications

Merves, Michele L.; Goldberger, Bruce A.

doi:10.1002/9780470023129.ch1

Cited by 5 publications

(4 citation statements)

References 14 publications

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“…Participants had not taken other medications (including over-the-counter drugs) for two weeks before or during the study period. The study was carried out according to the World Medical Association Declaration of Helsinki (1997) for biomedical research involving human subjects (30) and the Guideline for Good Clinical Practice (2008) (32). Based on this description, they provided written informed consent before participating in the study.…”

Section: Methods Assay Validationmentioning

confidence: 99%

Quantification of Galantamine in Human Plasma by Validated Liquid Chromatography-Tandem Mass Spectrometry using Glimepride as an Internal Standard: Application to Bioavailability Studies in 32 Healthy Korean Subjects

Park

Kim

et al. 2012

Journal of Chromatographic Science

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A simple, rapid and selective liquid chromatography method coupled with tandem mass spectrometry is developed and validated for the quantification of galantamine in human plasma using a commercially available compound, glimepride, as an internal standard (IS). Following simple one-step liquid-liquid extraction by ethyl acetate, the analytes are separated using an isocratic mobile phase consisting of acetonitrile and 0.01M ammonium acetate (95/5, v/v) on a reverse-phase C18 column and analyzed by tandem mass spectrometry in the multiple reaction monitoring mode using the transitions of respective (M + H)(+) ions, m/z 288.22 → 213.20 and m/z 491.17 → 352.30 for the quantification of galantamine and IS, respectively. The standard calibration curves show good linearity within the range of 4 to 240 ng/mL (r(2) = 0.9996, 1/x(2) weighting). The lower limit of quantification is 4 ng/mL. The retention times of galantamine and IS are 1.1 and 0.71 min, which showsthe high throughput potential of the proposed method. In addition, no significant metabolic compounds are found to interfere with the analysis. Acceptable precision and accuracy are obtained for the concentrations over the standard curve range. The validated method is successfully applied for pharmacokinetic and bioequivalence studies of 24 mg of a galantamine hydrobromide capsule in 32 healthy Korean subjects.

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Section: Methods Assay Validationmentioning

confidence: 99%

Quantification of Galantamine in Human Plasma by Validated Liquid Chromatography-Tandem Mass Spectrometry using Glimepride as an Internal Standard: Application to Bioavailability Studies in 32 Healthy Korean Subjects

Park

Kim

et al. 2012

Journal of Chromatographic Science

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“…This graphical approach determines variability on a process and whether it is due to chance (common causes) or attributable to a change in the process (assignable cause). [ 93,94 ] Set‐up informatics tools for the system, to collect, clean, and process data into a format that is easy to visualize. This step prepares data for the data‐mining phase and applies to process and catalyst performance data.…”

Section: Best Practises In Htctmentioning

confidence: 99%

Experimental methods in chemical engineering: High throughput catalyst testing — HTCT

et al. 2021

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The conventional one‐at‐a‐time strategy to evaluate catalysts is inefficient and resource intensive. Even a fractional factorial design takes weeks to control for temperature, pressure, composition, and stability. Furthermore, quantifying day‐to‐day variability and data quality exacerbates the time sink. High‐throughput catalyst testing (HTCT) with as many as 64 parallel reactors reduces experimental time by two orders of magnitude and decreases the variance, as it is capable of quantifying random errors. This approach to heterogeneous catalyst development requires dosing each reactor precisely with the same flow and composition, controlling the temperature and identifying the isothermal zone, on‐line analysis of the gas‐phase, and a common back pressure regulator to maintain constant pressure. Silica capillary or microfluidic distribution chip manifolds split a common feed stream precisely (standard deviation <0.5%), thus guaranteeing reproducibility. With these systems, experimenters shift their focus from operating a single reactor to careful catalyst synthesis, sometimes delicate catalytic reactor loadings, and the handling, processing, and analysis of massive amounts of data. This review presents an overview of the main elements of HTCT, its applications, potential sources of uncertainty, and a set of best practises derived from scientific literature and research experience. A bibliometric analysis of articles Web of Science indexed from 2015–2020 grouped research into five clusters: (1) discovery, directed evolution, enzymes, and complexes; (2) electrocatalysis, reduction, adsorption, and nanoparticles; (3) hydrogen, oxidation, and stability; (4) DFT, combinatorial chemistry, and NH3; and (5) graphene and carbon.

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“…Un sistema de calidad describe todos los procedimientos y los criterios adoptados por el laboratorio para asegurar la integridad de la muestra recibida, la continuidad de la cadena de custodia y la trazabilidad de los resultados analíticos 91,92 . La evaluación de los mecanismos de control se realiza mediante la participación en pruebas de aptitud 1,93 .…”

Section: Criterios De Calidad En La Interpretación Toxicológica Post unclassified

Interpretación de resultados toxicológicos post-mórtem: criterios de garantía de calidad

García-Repetto

2015

Revista Española de Medicina Legal

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Quality Assurance, Quality Control and Method Validation in Chromatographic Applications

Cited by 5 publications

References 14 publications

Quantification of Galantamine in Human Plasma by Validated Liquid Chromatography-Tandem Mass Spectrometry using Glimepride as an Internal Standard: Application to Bioavailability Studies in 32 Healthy Korean Subjects

Quantification of Galantamine in Human Plasma by Validated Liquid Chromatography-Tandem Mass Spectrometry using Glimepride as an Internal Standard: Application to Bioavailability Studies in 32 Healthy Korean Subjects

Experimental methods in chemical engineering: High throughput catalyst testing — HTCT

Interpretación de resultados toxicológicos post-mórtem: criterios de garantía de calidad

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