The first RP-UHPLC method for simultaneous quantification of abiraterone acetate, its four degradants, and six specified process impurities and correct identification of all analytes based on molecular weight.

This article describes the first simple, fast, time-saving, and cost-effective UHPLC method that was developed and validated for simultaneous quantification of abiraterone acetate, its four degradation products, and six specified process impurities in bulk and tablet form. Moreover, when coupled with a mass spectrometer detector, the proposed method provides additional advantages for confirmation of peak and correct identification based on molecular weight. The eleven peaks were separated on a Water Acquity BEH C18, (150 mm length, 2.1 mm internal diameter, 1.7 µm particle size) column maintained at a 50.0 °C temperature. Using 0.05% formic acid in 10 mM ammonium formate, acetonitrile, and methanol as mobile phases in gradient elution at a flow rate of 0.40 mL/min. provides excellent separation at 260 nm. The linearity curves of all analytes showed promising results with a correlation coefficient of 0.999 with a lower limit of detection and quantification. A forced degradation study on solid abiraterone acetate proved its specificity with improvements and significance. This proposed method provides improved separation with a lower flow rate, which offers faster analysis, reduces wastage and cost, and specifies the greener advantages compared to reported methods. The outcome of the specificity, linearity, precision, and trueness as per ICH guidelines proved that the proposed method is fast, time-saving, and cost-effective for the intended purpose. [Display omitted] • MS-compatible UHPLC method established for qualitative and quantitative analysis. • Helpful for quantification of active, its four degradants, and six process impurities. • Determination of eleven analytes with improved speed, separation, and sensitivity. • Successfully applied the method for batches of API and tablets of abiraterone acetate. • Correct identification and confirmation of all analytes based on molecular weight. [ABSTRACT FROM AUTHOR]