Validation of a method for the assay of related compounds in famotidine raw materials and formulations.

Abstract A high-performance liquid chromatographic (HPLC) method has been developed for the determination of famotidine and related compounds in drug raw materials and formulations. The minimum detectable amount of the available related compounds is less than 0.02% and the minimum quantifiable amount is less than 0.1%. Famotidine impurity levels were between 0.5 and 2.5% in raw materials, 0.44% in one tablet sample and about 3% in an IV solution, allowing for stabilizers.