Abstract
A rapid, precise, and eco-friendly reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of sitagliptin and metformin in combined dosage forms. Chromatographic separation was achieved on a C18 column using an optimized mobile phase that provided sharp, symmetric peaks with adequate resolution within a short analysis time. The method exhibited excellent linearity over the concentration range of 0.5–50 µg/mL for both analytes, with correlation coefficients (r²) exceeding 0.999. Recovery studies confirmed accuracy within 98–102%, while precision values expressed as relative standard deviation (RSD) remained below 2%, satisfying the acceptance criteria outlined by ICH Q2(R1). The limits of detection and quantitation demonstrated high sensitivity, and robustness testing confirmed the method’s resilience to small variations in analytical parameters. Stability assessment of standard and sample solutions indicated no significant degradation over 48 hours. Greenness evaluation using Analytical Eco-Scale and AGREE metrics yielded scores above 75 and 0.8, respectively, classifying the procedure as environmentally benign. Overall, the validated method is reliable, reproducible, and sustainable, making it suitable for routine quality control and stability evaluation of pharmaceutical formulations containing sitagliptin and metformin.