Journal
BIOMEDICAL CHROMATOGRAPHY
Volume 31, Issue 11, Pages -Publisher
WILEY
DOI: 10.1002/bmc.3986
Keywords
abiraterone; abiraterone acetate; LC-MS/MS; stability; validation
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Funding
- Janssen Cilag
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A method was developed and validated to quantify abiraterone in human plasma. During assay development, several analytical challenges were encountered: limited stability in patient samples, adsorption to glass, coelution with metabolites and carry-over issues. Limited stability (2h) was found for abiraterone in fresh plasma as well as whole blood at ambient temperature. When kept at 2-8 degrees C, abiraterone in plasma was stable for 24h and in whole blood for 8h. Adsorption of abiraterone to glass materials was addressed by using polypropylene throughout the method. Carry-over was reduced to acceptable limits by incorporating a third mobile phase into the gradient. The chromatographic separation of abiraterone with its multiple metabolites was addressed by using a longer analytical column and adjusting the gradient. Abiraterone was extracted by protein precipitation, separated on a C18 column with gradient elution and analyzed with tandem quadrupole mass spectrometry in positive ion mode. A stable deuterated isotope was used as the internal standard. The assay ranges from 1 to 500 ng/mL. Within- and-between-day precisions and accuracies were below 13.4% and within 95-102%. This bioanalytical method was successfully validated and applied to determine plasma concentrations of abiraterone in clinical studies and in regular patient care for patients with metastatic castration-resistant prostate cancer.
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