A Pre-Column Derivatization Method for the HPLC-FLD Determination of Dimethyl and Diethyl Amine in Pharmaceuticals.

ABSTRACT: In recent years, the detection of nitrosamine precursors has become an important issue for regulatory authorities such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). The present study provides a pre-column derivatization method for the analysis of dimethylamine (DMA) and diethylamine (DEA) in pharmaceutical products using HPLC and a fluorescence detector. Appropriate chromatographic parameters, including mobile phase composition (organic solvent, buffer, pH), elution type, flow rate, temperature, and λexcitation/emission, were investigated. Analysis was performed at λ_excitation = 450 nm and λ_emission = 540 nm on a C₁₈ column (at 40 °C) using gradient elution as a mobile phase with Eluent A: Phosphoric Acid Buffer (20 mM,

SUBMITTER: Kamaris G 

PROVIDER: S-EPMC11643484 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature