Reversed-phase determination of famotidine, potential degradates, and preservatives in pharmaceutical formulations by high-performance liquid chromatography using silica as a stationary phase.

An analytical method was developed for the determination of famotidine, potential degradates, and preservatives in several pharmaceutical formulations. The method employs reversed-phase chromatography on a silica column with a methanol-phosphate solution as the mobile phase. The influence of the concentration of phosphate and organic modifier are discussed. Accuracy and precision for this method along with assay data from different formulations of famotidine are presented. Two different commercial silica columns were tested with this method. Chromatographic differences related to the surface area and pore size of the silica are discussed.