Sample Preparation in LC‐MS Bioanalysis

doi:10.1002/9781119274315

Cited by 17 publications

(1 citation statement)

References 58 publications

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“…In LC-MS/MS bioanalysis, sample preparation requires the selective isolation of the studied analytes from the matrix, the removal or minimization of matrix effect, and if necessary, analyte enrichment. Owing to the various factors that affect analyte recovery and matrix removal, designing an effective sample preparation method is considered one of the most critical aspects of developing an LC-MS/MS bioanalytical method (Li et al, 2019). Accordingly, several trials were carried out in order to optimize the extraction procedure to achieve the maximum recovery for all analytes while minimizing the matrix effect.…”

Section: Optimization Of Sample Preparation Methodsmentioning

confidence: 99%

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

Abdel‐Megied

Kovalenko

Elbarbry

et al. 2023

Biomedical Chromatography

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In this study, the development and validation of an accurate and highly sensitive LC–MS/MS method were performed for the estimation of nifedipine, bisoprolol and captopril in real human plasma. Liquid–liquid extraction using tert‐butyl methyl ether was efficiently applied for extraction of the analytes from plasma samples. The chromatographic separation was carried out using an isocratic elution mode on the X‐terra MS C18 column (4.6 × 50 mm, 3.5 μm). The mobile phase consisted of methanol–0.1% formic acid (95:5, v/v) for determination of nifedipine and bisoprolol and acetonitrile–0.1% formic acid (70:30, v/v) for determination of captopril with a flow rate of 0.5 ml/min. Acceptable results regarding the different validation characteristics of the analytes were obtained in accordance with US Food and Drug Administration recommendations for bioanalytical methods. The developed approach was linear over concentration ranges of 0.5–130.0, 50.0–4,500.0 and 0.3–30.0 ng/ml for nifedipine, captopril and bisoprolol, respectively. The method revealed a sufficient lower limit of quantification in the range of 0.3–50.0 ng/ml, as well as high recovery percentages, indicating high bioanalytical applicability. The proposed method was efficiently applied to a pharmacokinetic evaluation of a fixed‐dose combination of the analytes in healthy male volunteers.

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Section: Optimization Of Sample Preparation Methodsmentioning

confidence: 99%

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

Abdel‐Megied

Kovalenko

Elbarbry

et al. 2023

Biomedical Chromatography

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Toxicokinetics in preclinical drug development of small‐molecule new chemical entities

Picard

2022

Biomedical Chromatography

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Toxicokinetics (TK) is an integral part of nonclinical (preclinical) safety assessment of small-molecule new chemical entities in drug development. It is employed to describe the systemic exposure of a drug candidate and/or its important metabolite(s) achieved in study animals and elucidate the relationship (proportional, over-proportional, or under-proportional) between systemic exposure and dose administered and the associated differences/similarities between male and female animals along with the possible accumulation/induction. TK data and the derived parameters are employed to propose safe starting doses for clinical use of the new drug candidate through proper extrapolation of findings in study animals to humans. This review has attempted to highlight the health authority expectations on TK assessment in supporting preclinical safety profiling of new chemical entities. A robust TK assessment requires good understanding of absorption, distribution, metabolism, and elimination processes of drug candidate, adequate TK sampling (e.g., controls where relevant), implementation of fit-for-purpose bioanalytical methods (validated or scientifically qualified) along with necessary measures to prevent mis-dosing or ex vivo contamination, and establishment of stability of the drug candidate and/or its metabolite(s) in the intended species matrix to ensure the reliability of bioanalytical and TK data. The latter provides a vital link between animal experiments and human safety.

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Strategies for automating analytical and bioanalytical laboratories

Thurow

2023

Anal Bioanal Chem

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Analytical measurement methods are used in different areas of production and quality control, diagnostics, environmental monitoring, or in research applications. If direct inline or online measurement methods are not possible, the samples taken have to be processed offline in the manual laboratory. Automated processes are increasingly being used to enhance throughput and improve the quality of results. In contrast to bioscreening, the degree of automation in (bio)analytical laboratories is still low. This is due in particular to the complexity of the processes, the required process conditions, and the complex matrices of the samples. The requirements of the process to be automated itself and numerous other parameters influence the selection of a suitable automation concept. Different automation strategies can be used to automate (bio)analytical processes. Classically, liquid handler-based systems are used. For more complex processes, systems with central robots are used to transport samples and labware. With the development of new collaborative robots, there will also be the possibility of distributed automation systems in the future, which will enable even more flexible automation and use of all subsystems. The complexity of the systems increases with the complexity of the processes to be automated. Graphical Abstract

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Sample Preparation in LC‐MS Bioanalysis

Abstract: Merbel, van de, N. (2019). Sample preparation for LC-MS bioanalysis of proteins. In W. Li, W. Jian, & Y. Fu (Eds.), Sample preparation in First Edition (1st ed.,. Wiley.

Cited by 17 publications

References 58 publications

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

Toxicokinetics in preclinical drug development of small‐molecule new chemical entities

Strategies for automating analytical and bioanalytical laboratories

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