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HPLC-UV Method Development for the Determination of EDTA in Oxycodone HCl Oral Liquids with Derivatization Technique. Robustness by Design of Experiments Approach

A. K. Palakurthi,Thirupathi Dongala

Published 2019 in Analytical Chemistry Letters

ABSTRACT

Abstract This study deals with a simple and precise analytical method development and validation of a comprehensive high performance liquid chromatography method for estimation of Edetate disodium (EDTA) in liquid formulations. The effective chromatographic separation of EDTA was achieved with a X Bridge C-8 column with isocratic elution of mobile phase composed of buffer, methanol and water (175:90:675 v/v/v). The buffer used in mobile phase contained 0.06 % of tetra butyl ammonium hydroxide and adjusted pH to 7.5 ± 0.05 with 86 % of ortho phosphoric acid. The HPLC instrument flow rate was 2.0 mL min−1 and UV-detector wavelength was set 259 nm for the quantification of EDTA. The column oven temperature was 45°C. The derivatization of EDTA was carried out using 1 % copper acetate solution to form a UV active chromophore group. Proved the robustness of the method by using Design of Experiments study. The correlation coefficient for EDTA was >0.9998 and linearity range was found to be 25-75 μg mL−1. The mean recovery values were found to 98.3 (50 % level), 98.8 (100 % level) and 98.4 (150 % level). Further, specificity of the current method was proved by separating the placebo peaks. The proposed validated HPLC method was successfully applied for the determination of EDTA in Oxycodon HCl oral solutions.

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