Development of a simple RP-HPLC method for the determination of EDTA residue in pharmaceutical clean-in-place (CIP) applications

A reversed-phase method was developed for the determination of EDTA (ethylenediaminetetraacetic acid) in a clean-in-place detergent through HPLC connected with UV or PDA detector. The EDTA signal was well above the detection limit and no interference was observed from water sample or any other swab and rinse diluent. The purpose of this study is to develop a simple, cost-effective reversed-phase HPLC method for the identification and quantification of EDTA in the cleaning solution. This method may contribute to further development and validation of residue detection from cleaning solutions used in pharmaceutical manufacturing. A HPLC system connected with UV detector and a column, Hamilton PRP-X100, 250 mm long x 4.1 mm internal diameter, 5 μm-thick was used to develop this method. This method is specific and precise for EDTA determination. The %RSD for six replicate injections was found to be within 10.0%. This method can be applied to cleaning validation samples and should be validated according to ICH guidelines before being used to analyze cleaning validation samples.