Method development for the determination of cefdinir and its related substances by high-performance liquid chromatography

Abstract The validation of the HPLC method used for the determination of cefdinir and its related substances is described. The developed method was specific and stability-indicating and provided a linear response with concentration. The system and method precision, expressed as relative standard deviations, were not greater than 1%, and the reproducibilities within and between laboratories were acceptable for the assay method. The procedure can quantitate related substances greater than approximately 0.05% of the principal cefdinir peak.