An LC-MS/MS method for quantification of the active abiraterone metabolite Δ(4)-abiraterone (D4A) in human plasma.

Δ(4)-Abiraterone (D4A) is a recently discovered active metabolite of the oral anti-androgen drug abiraterone acetate. For quantification of this metabolite in human plasma, a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated. Human plasma samples of patients treated with abiraterone acetate were prepared by protein precipitation with acetonitrile. The method was validated over a linear range of 0.2-20ng/mL. Intra-assay and inter-assay variabilities were within ±15% of the nominal concentrations for quality control (QC) samples at medium and high concentrations and within ±20% at the lower limit of quantification (LLOQ), respectively. The described method for quantification of D4A was validated successfully and implemented to support therapeutic drug monitoring in patients treated with abiraterone acetate.