QbD-Based Development and Validation of an Efficient RPHPLC Method for Estimation of Abiraterone Acetate in Bulk, Tablet, and In-House-Developed Nano-Formulation

Abstract

The present study focused on the development of a simple, reliable, cost-effective, precise, and stable quality by design (QbD) RP-HPLC method for estimation of Abiraterone Acetate in bulk, pharmaceutical dosage form, and in-house-developed nano-formulation. The essential analytical target profile (ATP), and critical analytical attributes (CAAs) were described. Plackett-Burman Design and Box-Behnken Design were used for screening and optimization of critical method parameters (CMPs). The chromatographic method with reverse-phase isocratic mode, C-18 column, 69: 31 (% v/v) acetonitrile, and ammonium acetate buffer (pH 3.5) as a mobile phase with a flow rate of 0.75 ml/min and 235 nm detection wavelength was developed. The method was validated as per International Conference on Harmonization guideline and found to be linear between 10 to 180 μg/ml with R2 0.997, detection limit of 3.64 μg/ml, and quantitation limit of 11.05 μg/ml. Precision was demonstrated using a relative standard deviation of 1.55 % and 1.59 % for inter and intraday studies respectively. The developed method was also used for the analysis of ABT in bulk, tablet dosage form, and in-house-developed nanosponges prepared using different cross-linking agents, devoid of any interference of formulation excipients. The method effectively established the utility of QbD for optimizing chromatographic conditions used for the estimation of Abiraterone acetate.