Advanced Methodology for developing and validating esomeprazole-domperidone combinations in pharmaceutical research

A robust analytical method was developed and validated for the simultaneous estimation of Esomeprazole and Domperidone in pharmaceutical formulations. The identity of both drugs was confirmed using UV-Visible Spectroscopy and Fourier Transform Infrared (FTIR) Spectroscopy. FTIR analysis demonstrated characteristic functional group peaks, ensuring drug stability and compatibility. UV-Visible spectroscopy revealed absorption maxima at 301 nm and 284 nm for Esomeprazole and Domperidone, respectively, confirming their detectability. High-Performance Liquid Chromatography (HPLC) was optimized using a C18 column and a mobile phase of Buffer (pH 6.8), Methanol, and Acetonitrile (50:25:25). The retention times were 4.1 min and 5.1 min, ensuring peak resolution and method reliability. Method validation confirmed linearity, accuracy (>98% recovery), precision (RSD < 2%), and sensitivity (LOD and LOQ within limits). Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the method’s stability-indicating nature. Minimal degradation occurred under dry heat and photolysis, while acidic, alkaline, and oxidative conditions showed degradation peaks. The developed HPLC method efficiently separated the drugs from degradation products, ensuring its reliability for pharmaceutical quality control and stability studies. These findings confirm the method&#39;s applicability for routine analysis in pharmaceutical formulations.