Pintu Prajapati, Shabbir Kattahwala, Dhrumi Naik, Veerashakar Pulusu, Md. Anzarul Haque, Sarfaraz Ahmad, Shailesh Shah
ABSTRACT The objective was to develop and validate a stability‐indicating chromatographic method for concurrent estimation of sitagliptin and glimepiride in tablets and forced degradation samples using an integrated approach of white analytical chemistry and risk‐based analytical quality by design. The liquid chromatographic method was developed using a Shim‐pack octadecyl silane column with a mobile phase of acetonitrile and water (30:70, v/v, pH 3.5). The method was optimized using quality by design principles and validated according recommended standard guidelines. Forced degradation studies were conducted under various stress conditions. The method was applied to in‐house prepared tablets and forced degraded samples. The optimized method showed good linearity for both drugs. Precision and accuracy were within acceptable limits. The method demonstrated stability‐indicating capability, effectively separating degradation products. Assay results for in‐house tablets were 101.12% for sitagliptin and 99.83% for glimepiride. The developed liquid chromatographic method, integrating white analytical chemistry and analytical quality by design principles, proved to be robust, sensitive, and eco‐friendly, achieving a superior greenness profile with an analytical greenness score of 0.77 compared to published methods.