ABSTRACT:
Empagliflozin is a selective sodium–glucose co-transporter-2 (SGLT2) inhibitor used in the treatment of type 2 diabetes mellitus. The present study focuses on the development and optimization of a stability-indicating RP-HPLC method using an Analytical Quality by Design (AQbD) approach. Critical analytical parameters such as mobile phase composition, flow rate, and detection wavelength were systematically optimized using a Central Composite Design (CCD). The Analytical Target Profile (ATP) was defined to ensure method robustness and reliability. Validation was performed as per ICH Q2(R1) guidelines. The method showed excellent linearity (R² > 0.999), accuracy (98–102%), and precision (%RSD < 2). Forced degradation studies confirmed specificity and stability-indicating capability. The developed method is robust, reproducible, and suitable for routine quality control analysis.