Development and Validation of Stability Indicating Method for Simultaneous Estimation of Famotidine and Domperidone in Bulk and Tablet Dosage Forms Using RP-HPLC

A novel, precise, and accurate Reverse Phase-High Performance Liquid Chromatography (RP- HPLC) method was developed and validated for the simultaneous estimation of Famotidine (FAM) and Domperidone (DOM) in bulk and tablet dosage forms. The method was optimized using a Symmetry C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of 0.002 M Sodium dihydrogen phosphate buffer (pH 5.8) and acetonitrile (60:40, v/v) at a flow rate of 1 mL/min. Detection was performed at 287 nm using a Photo Diode Array (PDA) detector. The retention times for FAM and DOM were 3.216 min and 5.762 min, respectively, with a resolution of 10.10. The method demonstrated linearity in the range of 5-30 µg/mL for FAM and 2.5-15 µg/mL for DOM, with correlation coefficients r2 of 0.999 for both drugs. The method was validated as per ICH guidelines, showing excellent accuracy (recovery 99.45%-99.73% for FAM and 99.33%-100% for DOM), precision (RSD < 2%), and robustness. Forced degradation studies under acid, alkali, oxidative, thermal, and photolytic conditions confirmed the stability-indicating nature of the method. FAM was more sensitive to alkali hydrolysis, while DOM showed sensitivity to both acid and alkali hydrolysis. The method was successfully applied to the analysis of commercial tablet formulations, with no interference from excipients. The developed RP-HPLC method is simple, rapid, and reliable, making it suitable for routine quality control and stability studies of FAM and DOM in combined dosage forms.