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Determination of naloxegol in human biological matrices
Yan Li1, Mark Hoffmann2, Paul Severin2
1Clinical Sample Science, Early Clinical Development, AstraZeneca, 35 Gatehouse Drive, Waltham, MA 02451, USA.
Aim:
Naloxegol is an oral peripherally acting μ-opioid receptor antagonist approved for the treatment of opioid-induced constipation. Sensitive, robust, bioanalytical methods were required to quantitate naloxegol in human biological matrices as part of the clinical development program.
Methodology/Results:
Analytical plasma samples were prepared using Solid Phase Extraction (SPE) coupled with concentration. The method's linearity was established at 0.1-50 ng/ml with up to 100-fold dilution. Urine samples were analyzed directly postdilution; dialysate samples were extracted by supported liquid extraction. Sensitive liquid chromatography/mass spectrometry (LC-MS/MS) assays were developed and validated, and demonstrated acceptable precision, accuracy and selectivity for naloxegol in the appropriate matrices.
Conclusion:
Methods for quantifying naloxegol in human biological matrices have been successfully validated.
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