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Updated: May 9, 2026
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A Practical Guide on Coupling a Scanning Mobility Sizer and Inductively Coupled Plasma Mass Spectrometer (SMPS-ICPMS)
Published on: July 11, 2017
Technical aspects of inductively coupled plasma bioanalysis techniques
Jennifer Ammerman1, Chaoyang Huang, Jeffrey Sailstad
1MPI Research, 54943 N. Main Street, Mattawan, MI 49071, USA. jennifer.ammerman@ mpiresearch.com
Bioanalysis
|August 3, 2013
Summary
This paper discusses quantifying inorganic elements in biological samples for pharmaceutical studies using inductively coupled plasma (ICP) techniques. It highlights challenges with current regulations and endogenous elements impacting accurate quantification.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Bioanalysis
Background:
- Inductively Coupled Plasma (ICP) techniques have a long history in environmental analysis and are increasingly used in the pharmaceutical industry.
- Existing bioanalytical method validation and sample analysis regulatory guidance are primarily designed for chromatographic methods and may not fully address ICP techniques.
- Quantifying inorganic elements in biomatrices is crucial for pharmaceutical development, including nonclinical and clinical studies.
Purpose of the Study:
- To address the technical aspects of quantifying pharmaceutically derived inorganic elements in biomatrices.
- To support Good Laboratory Practice (GLP) nonclinical and clinical studies.
- To provide insights into the application of ICP techniques in pharmaceutical bioanalysis.
Main Methods:
- Focus on inductively coupled plasma mass spectrometry (ICP-MS), including quadrupole and high-resolution ICP-MS.
- Discusses the quantification of inorganic elements in pharmaceutical compounds and biological matrices.
- Highlights the importance of method validation and sample analysis for ICP techniques.
Main Results:
- ICP techniques, particularly ICP-MS, are increasingly employed for quantifying inorganic elements in pharmaceutical contexts.
- Current regulatory guidance for bioanalytical methods may not be fully applicable to all aspects of ICP techniques.
- Endogenous elements present in biomatrices can significantly impact the quantification of blanks, standard curves, quality control samples, and the lower limit of quantification (LLOQ).
Conclusions:
- There is a need for tailored validation and regulatory considerations for ICP techniques in pharmaceutical bioanalysis.
- Understanding and managing the impact of endogenous elements is critical for accurate inorganic element quantification in biomatrices.
- The application of ICP-MS offers advanced capabilities for elemental analysis in pharmaceutical research and development.
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