European Journal of Biomedical and Pharmaceutical Sciences

DETERMINATION OF 2, 4 DIFLUORONITROBENZENE AS A GENOTOXIC IMPURITY IN FLURBIPROFEN DRUG SUBSTANCE BY USING UPLC

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 2, 4 Difluoronitrobenzene in Flurbiprofen. Chromatographic separation between 2, 4 Difluoronitrobenzene and Flurbiprofen was achieved using a C18 column using a mobile phase containing buffer and acetonitrile in gradient mode. The resolution between the between 2, 4 Difluoronitrobenzene and Flurbiprofen was found to be more than 5.0. The limit of detection (LOD) and limit of quantification (LOQ) of the 2, 4 Difluoronitrobenzene was 0.11 and 0.22 μg mL-1 respectively, for 3 μL injection volume. The percentage recoveries of the 2, 4 Difluoronitrobenzene ranged from 90.36% to 92.84% 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, 2, 4 Difluoronitrobenzene, Genotoxic, UPLC.