Analytical Quality by Design Based HPLC for Quantitative Analysis of Teneligliptin and Rosuvastatin Calcium Tablets in the Presence of Force Degradation Products
Rashmin B. Patel, Jeel Shah, Mrunali R. Patel
Abstract
ABSTRACT The application of analytical quality by design in developing an HPLC method ensures robust, reliable, and regulatory‐compliant pharmaceutical analysis. This study aimed to establish a stability‐indicating HPLC for the quantification of teneligliptin and rosuvastatin calcium in tablets using analytical quality by design principles. The analytical target profile was defined, and a risk assessment identified critical method attributes and critical method parameters. A Plackett–Burman design screened significant critical method parameters, followed by optimization using a central composite design. The optimized method utilized a Phenomenex Gemini C18 column with a mobile phase of phosphate buffer (pH 5.0) and ACN (64:36% v/v), achieving retention times of 4.27 ± 0.2 min for teneligliptin and 11.84 ± 0.2 min for rosuvastatin. The HPLC method was validated as per International Council for Harmonisation (ICH) guidelines, demonstrating good linearity across concentration ranges of 20–60 µg/mL of teneligliptin and 10–30 µg/mL of rosuvastatin, respectively. Forced degradation studies under various stress conditions confirmed the method's specificity, ensuring reliable detection of teneligliptin and rosuvastatin even in the presence of degradation products. This study offers an innovative and efficient solution for the analysis of teneligliptin and rosuvastatin in combined fixed‐dose tablet formulations.