Comparative In-Vitro Dissolution and HPLC Analysis of Metformin-Sitagliptin Combination: A Study of the Iraqi Pharmaceutical Market

Abstract

The study aimed to evaluate in vitro dissolution profiles and bioequivalence of three metformin-sitagliptin combination drug products Janumet (Reference Product), SITAVIA PLUS and Sitaglamet products available in the Iraqi pharmaceutical market. A dissolution profile was running using a validated HPLC method in 0.025 M NaCl media following the Dissolution Test at 37°C. HPLC used an LC-20AD Shimadzu binary pump, an SPD-20A detector operating under isocratic conditions at a flow rate of 1 mL/min and detection wavelength was set up at 208 nm. difference factor (f1) values of metformin 0.48 and 0.89 with sitagliptin for SITAVIA PLUS, and 2.79 and 1.10 for Sitaglamet were obtained, indicating minimal differences compared with Janumet. Furthermore, similarity factor (f2) of 89.82, 85.01 with metformin and sitagliptin for SITAVIA PLUS, and 67.75, 70.86 for Sitaglamet was obtained indicating equivalence. The study concluded that all products released over 90% of their products within 30 minutes with Sitaglamet demonstrating faster initial release. The results of this study emphasize the importance of utilizing HPLC to accomplish accurate quantification of in-vitro drug release, allowing the substitution of Sitaglamet or SITAVIA PLUS for Janumet. Additionally, rigorous quality control testing is critical in guaranteeing patient safety and treatment.