Quality by design approach in HPLC method development and validation for simultaneous determination of abiraterone acetate and prednisolone with greenness assessment

Priya Jagtap; Dr. Reshma Jadhav; Dr. Ashish Jain; Bhavesh Mahajan; Prapti Gawand; Prathamesh Chaudhari; Aishwarya Patil

doi:10.56782/pps.369

Published : 2025-08-05

Vol. 23 No. 3 (2025)

Quality by design approach in HPLC method development and validation for simultaneous determination of abiraterone acetate and prednisolone with greenness assessment

Priya Jagtap

Dr. Reshma Jadhav

Dr. Ashish Jain

Bhavesh Mahajan

Prapti Gawand

Prathamesh Chaudhari

Aishwarya Patil

DOI: https://doi.org/10.56782/pps.369

Abstract

A Quality by Design (QbD) approach was employed to develop and optimize a novel and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of abiraterone acetate (ABTA) and prednisolone (PDS) in the pharmaceutical dosage form. The optimized method parameters were determined using a Central Composite Design (CCD) and included a run time of 8 minutes, the flow rate of 0.8 mL//min, and a column temperature of 25°C. The mobile phase comprised methanol and acetonitrile (90:10v/v) with detection at 260 nm. Retention times of 5.23 minutes for ABTA and 3.335 minutes for PDS were achieved, ensuring efficient separation with high resolution and minimal tailing. Method validation confirmed precision, accuracy, linearity, robustness, and system suitability in compliance with ICH guidelines, establishing the method’s reliability for routine use. Green analytical chemistry assessment using GAPI, AGREE, HPLC-EAT, and BAGI tools highlighted the method’s environmental sustainability, practicality, and safety. The development of this method supports efficient quality control by providing a precise, eco-friendly analytical solution for simultaneous drug analysis. Additionally, its adaptability for future pharmaceutical applications makes it a valuable tool for enhancing process efficiency and meeting sustainability goals.

Keywords:

Abiraterone acetate, Prednisolone, Quality by Design (QbD), High-Performance Liquid Chromatography (HPLC), Greenness

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Jagtap, P., Jadhav, D. R., Jain, D. A., Mahajan, B., Gawand, P., Chaudhari, P., & Patil, A. (2025). Quality by design approach in HPLC method development and validation for simultaneous determination of abiraterone acetate and prednisolone with greenness assessment. Prospects in Pharmaceutical Sciences, 23(3), 84–96. https://doi.org/10.56782/pps.369

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