Development, Validation, and Greenness Assessment of Eco-Friendly Analytical Methods for the Determination of Abiraterone Acetate in Pure Form and Pharmaceutical Formulations

• Published in: Separations 2024-10, Vol.11 (10), p.290
• Main Author: Akbel, Erten
• Format: Article
• Language: English
• Subjects: Abiraterone Acetate; Acetates; Analysis; Chemicals; Chromatography; Column chromatography; Correlation coefficients; Efficiency; Environmental sustainability; Ethanol; Formic acid; green analytical methods; Green chemistry; High performance liquid chromatography; HPLC; Impact analysis; Instrument industry; Mass spectrometry; Mathematical analysis; Membrane filters; Methods; Organic acids; pharmaceutical validation; Pharmaceuticals; Pharmacokinetics; Plasma; Scientific imaging; Software; Solvents; Spectrophotometry; Statistical analysis; sustainable laboratory practices; Toxicity; Viscosity; Water
• ISSN: 2297-8739; 2297-8739
• DOI: 10.3390/separations11100290

This study presents the development and validation of environmentally friendly analytical methods for quantifying Abiraterone Acetate (AA) in both its pure form and commercial pharmaceutical formulations. An optimized High-Performance Liquid Chromatography (HPLC) method was developed using an Agilent Extend C18 column (250 mm × 4.6 mm, 5 μm) at 25 °C. The mobile phase consisted of formic acid and ethanol in isocratic mode, with a flow rate of 1.0 mL min−1, and detection was performed at 253 nm. The spectrophotometric method involved a comprehensive evaluation of AA’s spectral properties in various solvents, with ultrapure water providing the most suitable spectra for analysis at 253 nm. Both methods were validated according to ICH guidelines, demonstrating selectivity, linearity, accuracy, precision, detection and quantification limits, and robustness, with correlation coefficients exceeding 0.999 across the 5–30 μg mL−1 concentration range. Comparative statistical analysis using Student’s t-test and Fisher’s F-test showed no significant differences between the two methods. The environmental impact of both methods was assessed using AGREE and GAPI software, confirming their sustainability. These validated methods offer reliable and eco-friendly approaches for the quantitative analysis of AA in tablet formulations, promoting safer and greener laboratory practices in pharmaceutical analysis.