Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MSMS Method Validation Using Enalapril and Enalaprilat
Joint Authors
Burckhardt, Bjoern B.
Laeer, Stephanie
Source
International Journal of Analytical Chemistry
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-03-19
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Abstract EN
In USA and Europe, medicines agencies force the development of child-appropriate medications and intend to increase the availability of information on the pediatric use.
This asks for bioanalytical methods which are able to deal with small sample volumes as the trial-related blood lost is very restricted in children.
Broadly used HPLC-MS/MS, being able to cope with small volumes, is susceptible to matrix effects.
The latter restrains the precise drug quantification through, for example, causing signal suppression.
Sophisticated sample preparation and purification utilizing solid-phase extraction was applied to reduce and control matrix effects.
A scale-up from vacuum manifold to positive pressure manifold was conducted to meet the demands of high-throughput within a clinical setting.
Faced challenges, advances, and experiences in solid-phase extraction are exemplarily presented on the basis of the bioanalytical method development and validation of low-volume samples (50 μL serum).
Enalapril, enalaprilat, and benazepril served as sample drugs.
The applied sample preparation and extraction successfully reduced the absolute and relative matrix effect to comply with international guidelines.
Recoveries ranged from 77 to 104% for enalapril and from 93 to 118% for enalaprilat.
The bioanalytical method comprising sample extraction by solid-phase extraction was fully validated according to FDA and EMA bioanalytical guidelines and was used in a Phase I study in 24 volunteers.
American Psychological Association (APA)
Burckhardt, Bjoern B.& Laeer, Stephanie. 2015. Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MSMS Method Validation Using Enalapril and Enalaprilat. International Journal of Analytical Chemistry،Vol. 2015, no. 2015, pp.1-11.
https://search.emarefa.net/detail/BIM-1064444
Modern Language Association (MLA)
Burckhardt, Bjoern B.& Laeer, Stephanie. Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MSMS Method Validation Using Enalapril and Enalaprilat. International Journal of Analytical Chemistry No. 2015 (2015), pp.1-11.
https://search.emarefa.net/detail/BIM-1064444
American Medical Association (AMA)
Burckhardt, Bjoern B.& Laeer, Stephanie. Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MSMS Method Validation Using Enalapril and Enalaprilat. International Journal of Analytical Chemistry. 2015. Vol. 2015, no. 2015, pp.1-11.
https://search.emarefa.net/detail/BIM-1064444
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1064444