Stability-Indicating HPLC Method for Determination of Ibuprofen and Famotidine Degradation Products.

This article focuses on the development and validation of a novel stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantitative determination of ibuprofen, famotidine, and their degradation products in combined pharmaceutical formulations. The method employs a Zorbax SB-Phenyl column with a phosphate buffer (pH 3.0) and acetonitrile mobile phase, achieving separation of two active substances and seven related impurities within 35 minutes. Validation according to International Conference on Harmonization (ICH) guidelines confirmed the method's specificity, linearity, sensitivity (limit of detection and quantitation), precision, accuracy, robustness, and solution stability. This analytical approach addresses a gap in the literature, as no prior method simultaneously quantifies both active ingredients and their degradation products in combined ibuprofen-famotidine dosage forms, making it suitable for quality control during drug release and stability testing.