Determination of thalidomide concentration in human plasma by liquid chromatography-tandem mass spectrometry
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A rapid, sensitive and specific analytical method based on high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed for the determination of thalidomide concentration in human plasma. The analyte and internal standard were extracted by liquid-liquid extraction with ether-dichloromethane (3:2, v/v) and separated on a TC-C(18) column using methanol-10 mM ammonium acetate-formic acid (60:40:0.04, v/v/v) as the mobile phase at a flow rate of 0.9 ml/min. The detection was performed using an API 4000 triple quadrupole mass spectrometer in the positive electrospray ionization (ESI) mode and completed within 3.0 min. The multiple reaction monitoring (MRM) transitions were m/z 259.1→84.0 for the analyte and m/z 195.9→138.9 for temozolomide. The calibration curve exhibited a linear dynamic range of 2-1500 ng/ml (r>0.9991). The intra-and inter-day precisions (as relative standard deviation; RSD) were 6.8-13.5% and 4.3-5.0% respectively and the accuracy (as relative error; RE) was 2.0-3.5%. The recoveries and matrix effects were satisfactory in all the biological matrices examined. This method was successfully used in a pharmacokinetic study of thalidomide in healthy male volunteers receiving an oral administration of a 200-mg dose.
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The plasma concentration of thalidomide in humans is unlikely to exceed 10 μM.
“The plasma concentration of thalidomide in humans is, however, unlikely to exceed 10 µM (Bai et al., 2013; Dahut et al., 2009)”
From Thalidomide promotes degradation of SALL4, a transcription factor implicated in Duane Radial Ray syndrome (2018) · cites this paper as Bai et al., 2013
The Pharmacokinetic study (Results and Discussion) reports a mean peak plasma concentration of 2.40±0.26 μg/ml, approximately 9.3 μM. That supports the claim for the studied dose, but the study involved only 10 healthy male volunteers given a single 200-mg dose (Materials and methods); it does not establish a general upper limit for humans. (LLM, conf=0.85)
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References 26 · Cited by 16
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- Authors
- BAI, N., CUI, X.-Y., WANG, J., SUN, C.-G., MEI, H.-K., LIANG, B.-B., CAI, Y., SONG, X.-J., GU, J.-K., & WANG, R.
- Affiliations
- Chinese PLA General Hospital (CN)
- Corresponding author
- WANG, RUI
- Venue
- Experimental and Therapeutic Medicine
- Publisher
- Spandidos Publications
- Published
- 2012-11-30
- Volume
- 5
- Issue
- 2
- Pages
- 626-630
- ISSN
- 1792-0981 (ISSN-L)
- 1792-1015
- PMC
- PMC3570145
- OpenAlex
- W2058700178
- Cited by
- 16
- References
- 26
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 3 · 2022: 3 · 2019: 2 · 2018: 3 · 2016: 2
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Experimental and Therapeutic Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Jilin University
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- thalidomide, plasma drug concentration, pharmacokinetics, liquid-liquid extraction, multiple reaction monitoring, bioanalytical method validation, healthy volunteers
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