Method Development and Validation of Preservatives Determination (Benzyl Alcohol, Ethylene Glycol Monophenyl Ether, Methyl Hydroxybenzoate, Ethyl Hydroxybenzoate, Propyl Hydroxybenzoate, and Butyl Hydroxybenzoate) using HPLC

Abstract The purpose of the research described herein was to develop a new high performance liquid chromatography (HPLC) method for the assay of benzyl alcohol, ethylene glycol monophenyl ether, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, and butyl hydroxybenzoate preservatives. The use of a reversed‐phase C18 column (250 mm×4.0 mm and 5 µm) using a gradient elution system enabled six compounds to be separated simultaneously in a single chromatographic run in less than 12 minutes. The method was successfully validated following ICH guidelines, and it has been demonstrated to be reliable for the assay of benzyl alcohol, ethylene glycol monophenyl ether, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, and butyl hydroxybenzoate preservatives used in the manufacturing of drug products.