European Journal of Biomedical and Pharmaceutical Sciences

DETERMINATION OF DIETHYL (4-AMINO-3-FLUOROPHENYL) (METHYL) PROPANEDIOATE AS A GENOTOXIC IMPURITY IN FLURBIPROFEN DRUG SUBSTANCE BY USING HPLC

Vinayak Vele*, Amol Kumbhar Vishal Telvekar, Shivaji Kadam, Rupesh Kelaskar and Mohan Chandavarkar.

ABSTRACT

A simple and accurate method was developed for the determination of Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate in Flurbiprofen. Chromatographic separation between Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate and Flurbiprofen was achieved using a C18 column using a mobile phase containing buffer and acetonitrile in gradient mode. The resolution between the between Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate and Flurbiprofen was found to be more than 10.0. The limit of detection (LOD) and limit of quantification (LOQ) of the Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate was 0.05 and 0.10 μg mL-1 respectively, for 50 μL injection volume. The percentage recoveries of the Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate ranged from 96.79% to 112.43% in the samples of Flurbiprofen. The developed method was validated as per International Conference on Harmonization guidelines in terms of specificity, limit of detection, limit of quantification, precision, linearity, accuracy and ruggedness.

Keywords: Development, Validation, Flurbiprofen, Diethyl (4-amino-3-Fluorophenyl) (methyl) propanedioate, Genotoxic, HPLC