1*School of Pharmacy, Suresh Gyan Vihar University, Jaipur. ORCID ID: 0000-0002-4111-0439. Email: sachinshinde18@gmail.com
2Associate Professor, School of Pharmacy, Suresh Gyan Vihar University, Jaipur. ORCID: 0009-0000-3412-6961. Email: preeti.khulbe@mygyanvihar.com
Analytical control of anticancer drugs requires highly reliable quantification methods due to their therapeutic sensitivity and clinical significance. This study applies an Analytical Quality by Design (AQbD) framework to develop and validate RP-HPLC methods for acalabrutinib and capecitabine. The Analytical Target Profile was defined, and potential chromatographic factors were screened using risk assessment tools to identify critical method parameters for each drug. These parameters were optimized using a Box–Behnken response surface design to establish a statistically supported Method Operable Design Region (MODR), ensuring robust performance under variable analytical conditions.
Acalabrutinib was separated on a Zorbax XDB-C18 column (250 × 4.6 mm, 5 µm) using phosphate buffer (pH 6.4):methanol (80:20, v/v) at 1.0 mL·min⁻¹ with a 15-min run time. Capecitabine was determined on a Hypersil BDS C8 column (250 × 4.6 mm, 5 µm) using phosphate buffer (pH 4.0):acetonitrile (80:20, v/v) at 1.2 mL·min⁻¹ in 15 min.
The obtained MODR demonstrated a wide operational flexibility and enhanced method reliability for routine quality control. Validation according to ICH Q2 confirmed linearity (r² = 0.999), accuracy within 98–102%, precision with %RSD < 2%, robustness to deliberate variations, and 48-h solution stability. The developed AQbD-based methods are therefore suitable for routine pharmaceutical analysis of the selected anticancer drugs.
Keywords: Analytical Quality by Design, RP-HPLC, Anticancer, Method Development.
How to cite this article: Shinde SS, Khulbe P. Analytical Quality By Design Approach For Development Of Validated RP-HPLC Method For Estimation Of Acalabrutinib And Capecitabine In Their Respective Formulations. Int J Drug Deliv Technol. 2026;16(2): 792-801. DOI: 10.25258/ijddt.16.1.85
Source of support: Nil.
Conflict of interest: None