Abstract
DEVELOPMENT AND EVALUATION OF M-PHENYLENEDIAMINE AS A GENOTOXIC IMPURITY IN FLUCONAZOLE DRUG SUBSTANCE BY USING HPLC

Vinayak T. Vele*, Vishal Telvekar, Shivaji Kadam, Rupesh Kelaskar and Mohan A. Chandavarkar

ABSTRACT

A simple and accurate method was developed for the determination of M-Phenylenediamine in Fluconazole. Chromatographic separation between M-Phenylenediamine and Fluconazole was achieved using a C18 column using a mobile phase containing buffer and acetonitrile in gradient mode. The resolution between the between M-Phenylenediamine and Fluconazole was found to be more than 7.0. The limit of detection (LOD) and limit of quantification (LOQ) of the M-Phenylenediamine was 0.023 and 0.038 μg mL-1 respectively, for 50 μL injection volume. The percentage recoveries of the M-Phenylenediamine ranged from 93.2% to 115.7% in the samples of Fluconazole. 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, Fluconazole, M-Phenylenediamine, Genotoxic, HPLC.


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