ArticleJournal of pharmaceutical health care and sciences2025
Simultaneous measurement of apalutamide and N-desmethylapalutamide in human plasma using high-performance liquid chromatography with ultraviolet detection.
Article in Journal of pharmaceutical health care and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe combination of apalutamide, a nonsteroidal androgen receptor inhibitor, with androgen deprivation therapy enhances survival in patients with metastatic castration-sensitive prostate cancer. However, apalutamide exhibits complex pharmacokinetics and dose-dependent adverse effects, necessitating dose adjustments to optimize its therapeutic outcomes. To facilitate effective monitoring, a high-performance liquid chromatography (HPLC) system coupled with an ultraviolet (UV) detector was developed for quantifying plasma concentrations of apalutamide and its active metabolite, N-desmethylapalutamide. MAIN BODY: This method employed an ODS18 column (100 mm × 2.1 mm) with UV detection at 254 nm. The mobile phase comprised 20 mM acetate buffer (pH 5.0) and acetonitrile in a 60:40 ratio, and the run time was 10 min. The precision and accuracy were validated according to guidelines issued by the Food and Drug Administration (FDA). Long-term stabilities of the analytes were confirmed at both - 20 and - 80 °C over periods of 2 and 4 weeks. Peaks for enzalutamide (internal standard), N-desmethylapalutamide, and apalutamide were detected at 4.4, 5.8, and 7.7 min, respectively. Calibration curves demonstrated linearity within a concentration range of 0.5-20 µg/mL for both analytes in human plasma (R SHORT
conclusionThis work therefore presents a robust and simple HPLC-UV method for the simultaneous quantification of apalutamide and N-desmethylapalutamide in clinical therapeutic drug monitoring.
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