Evaluation of the RP-LC method for determining the pK<sub>a</sub> of abiraterone and its assay
摘要:
A straightforward, dependable, and quick RP-LC method for the analysis of abiraterone acetate in its dose form and human urine has been devised. With DAD detection, sensitivity was reported to be high. The LOD and LOQ of the procedure were deemed adequate. The suggested approach was exhaustively validated in accordance with ICH requirements, and the findings demonstrated that it was exact, accurate, selective, and sensitive for the analysis of this pharmaceutical. The chromatographic separation was realized using a X-Terra RP-18 (150 × 4.60 mm i.d. × 5 μm) column and a UV detector set at 255 and 267 nm. In addition, p K a values were calculated based on the relationship between the retention factor and the pH of the mobile phase. The influence of the composition of the mobile phase on the ionization constant was investigated by measuring the p K a at various acetonitrile–water combinations ranging from 50 to 70% (v/v).
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关键词:
IONIZATION constants ABIRATERONE acetate NONLINEAR regression EVALUATION methodology URINE RF values (Chromatography)
DOI:
10.1556/1326.2023.01173
年份:
2024
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