A Validated Method for the Estimation of EDTA in Drug Substances and their Intermediates by using Reversed Phase High Performance Liquid Chromatography

Ethylenediaminetetraacetic acid (EDTA) is widely used for the different purposes in pharmaceutical (bulk drug and formulations) industry; recent reports shows that EDTA exhibits low toxicity hence the detremination of content of EDTA is of prime importance. The method has been developed for the determination of EDTA contents accurately and precisely on HPLC using reversed phase C-18 HPLC column, by UV at 300 nm wavelength for detection. EDTA was determined by using its chelating property; mobile phase was mixed with a small amount of metal salt equivalent to about 50- 70μg per ml of metal ion. The method is validated for its specificity, precision, accuracy, linearity, ruggedness and robustness. EDTA is linear from 0.6μg/ml to 3.0μg/ml. Limit of quantitation for EDTA is 0.60 μg/ml and Limit of Detection is 0.30μg/ml.