Cost Effective Quantification of Trace Level EDTA (Ethylene Di-amine Tetra Acetic Acid) by Titrimetry in Active Pharmaceutical Ingredients

Abstract

Quantification of trace level EDTA (Ethylene di amine tetra acetic acid) content method was developed and optimized in Active Pharmaceutical Ingredients. The method was based up on the complexometric titration of metal with EDTA in presence of pH: 10 Buffer by using potentiometric titration. The optimized method was validated for different parameters like Linearity, Limit of detection (LOD),Limit of quantification (LOQ), System Precision, Method precision, Ruggedness, Robustness and accuracy .Based on the validation study limit of detection and limit of quantification of EDTA was found to be 0.0160 %w/w and 0.0350 %w/w respectively. The RSD of the system precision and method precision was found to be 4.12% and 8.22% respectively. The developed method was rugged and robust based on experiments. The recovery of the method is in the range of 98-100%.The developed method is cost effective and simple to estimate EDTA content in trace level in different drug substances.

Author(s): Cherukuru Nagaraju, Uttam Kumar Ray, Siddaiah Vidavalur

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