Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods
The emergence of metabolomics and quantification approaches is revealing new biomarkers applied to drug discovery. In this context, tandem mass spectrometry is the method of choice, requiring a specific validation process for preclinical and clinical applications. Research on the two classes of lipi...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Biomolecules |
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| Online Access: | https://www.mdpi.com/2218-273X/13/2/383 |
| _version_ | 1797622101865136128 |
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| author | Isabelle Matias Ilaria Belluomo Pierre-Louis Raux Monique Vallée |
| author_facet | Isabelle Matias Ilaria Belluomo Pierre-Louis Raux Monique Vallée |
| author_sort | Isabelle Matias |
| collection | DOAJ |
| description | The emergence of metabolomics and quantification approaches is revealing new biomarkers applied to drug discovery. In this context, tandem mass spectrometry is the method of choice, requiring a specific validation process for preclinical and clinical applications. Research on the two classes of lipid mediators, steroids and cannabinoids, has revealed a potential interaction in cannabis addiction and metabolism-related disorders. Here we present the development of GC-MS/MS and LC-MS/MS methods for routine quantification of targeted steroids and cannabinoids, respectively. The methods were developed using an isotopic approach, including validation for linearity, selectivity, LLOQ determination, matrix effect, carryover, between- and within-run accuracy and precision, and stability tests to measure 11 steroids and seven cannabinoids in human plasma. These methods were satisfactory for most validity conditions, although not all met the acceptance criteria for all analytes. A comparison of calibration curves in biological and surrogate matrices and in methanol showed that the latter condition was more applicable for our quantification of endogenous compounds. In conclusion, the validation of our methods met the criteria for GLP-qualified rather than GLP-validated methods, which can be used for routine analytical studies for dedicated preclinical and clinical purposes, by combining appropriate system suitability testing, including quality controls in the biological matrix. |
| first_indexed | 2024-03-11T09:06:29Z |
| format | Article |
| id | doaj.art-f1a3d76a3c4749e19934f7fb676ecfb1 |
| institution | Directory Open Access Journal |
| issn | 2218-273X |
| language | English |
| last_indexed | 2024-03-11T09:06:29Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Biomolecules |
| spelling | doaj.art-f1a3d76a3c4749e19934f7fb676ecfb12023-11-16T19:24:27ZengMDPI AGBiomolecules2218-273X2023-02-0113238310.3390/biom13020383Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation MethodsIsabelle Matias0Ilaria Belluomo1Pierre-Louis Raux2Monique Vallée3INSERM, Neurocentre Magendie, University of Bordeaux, U1215, F-33000 Bordeaux, FranceINSERM, Neurocentre Magendie, University of Bordeaux, U1215, F-33000 Bordeaux, FranceINSERM, Neurocentre Magendie, University of Bordeaux, U1215, F-33000 Bordeaux, FranceINSERM, Neurocentre Magendie, University of Bordeaux, U1215, F-33000 Bordeaux, FranceThe emergence of metabolomics and quantification approaches is revealing new biomarkers applied to drug discovery. In this context, tandem mass spectrometry is the method of choice, requiring a specific validation process for preclinical and clinical applications. Research on the two classes of lipid mediators, steroids and cannabinoids, has revealed a potential interaction in cannabis addiction and metabolism-related disorders. Here we present the development of GC-MS/MS and LC-MS/MS methods for routine quantification of targeted steroids and cannabinoids, respectively. The methods were developed using an isotopic approach, including validation for linearity, selectivity, LLOQ determination, matrix effect, carryover, between- and within-run accuracy and precision, and stability tests to measure 11 steroids and seven cannabinoids in human plasma. These methods were satisfactory for most validity conditions, although not all met the acceptance criteria for all analytes. A comparison of calibration curves in biological and surrogate matrices and in methanol showed that the latter condition was more applicable for our quantification of endogenous compounds. In conclusion, the validation of our methods met the criteria for GLP-qualified rather than GLP-validated methods, which can be used for routine analytical studies for dedicated preclinical and clinical purposes, by combining appropriate system suitability testing, including quality controls in the biological matrix.https://www.mdpi.com/2218-273X/13/2/383quantification methodstandem mass spectrometrysteroidscannabinoidshuman plasmaGC-MS/MS |
| spellingShingle | Isabelle Matias Ilaria Belluomo Pierre-Louis Raux Monique Vallée Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods Biomolecules quantification methods tandem mass spectrometry steroids cannabinoids human plasma GC-MS/MS |
| title | Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods |
| title_full | Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods |
| title_fullStr | Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods |
| title_full_unstemmed | Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods |
| title_short | Applied Clinical Tandem Mass Spectrometry-Based Quantification Methods for Lipid-Derived Biomarkers, Steroids and Cannabinoids: Fit-for-Purpose Validation Methods |
| title_sort | applied clinical tandem mass spectrometry based quantification methods for lipid derived biomarkers steroids and cannabinoids fit for purpose validation methods |
| topic | quantification methods tandem mass spectrometry steroids cannabinoids human plasma GC-MS/MS |
| url | https://www.mdpi.com/2218-273X/13/2/383 |
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