Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances

Haresh B. Patel

Analytical R&D, Cohance Lifesciences Ltd, Ankleshwar, India.

Rohit H. Dave *

Department of Industrial Chemistry, Institute of Science & Technology for Advanced Studies & Research, Vallabh Vidyanagar, Anand (Gujarat), India.

Sandip Vadariya

Analytical R&D, Cohance Lifesciences Ltd, Ankleshwar, India.

Hitin Hirpara

Chemical Research Synthesis R&D, Cohance Lifesciences Ltd, Ankleshwar, India.

Trushar Patel

Chemical Research Synthesis R&D, Cohance Lifesciences Ltd, Ankleshwar, India.

*Author to whom correspondence should be addressed.


Abstract

The assessment of toxicological concentrations of possible genotoxic contaminants in drug substances was regarded as an important and challenging discipline . The International Conference and Harmonization (ICH) recommended that most pharmaceutical products be allowed to include 1.5 μg/day of a genotoxic contaminant.  The goal  study was to develop a quick and accurate HPLC method for measuring potential genotoxic impurities (PGIs) in Dapson drug substances. The chromatographic conditions were appropriately optimized with the Phosphate and Acetate buffer on C18 & C8 columns to achieve a decent separation and response of each impurities peak with the Dapsone. A C8 column has been used with Phosphate buffer with the linear gradient combination with Acetonitrile as mobile phase and multiple wavelengths used based on UV maxima of respective impurity. According to International conference of Harmonization (ICH) criteria for the quantification of each impurity, method validation for HPLC was carried out regarding specificity, the limit of detection (LOD), the limit of quantification (LOQ), linearity, accuracy (recovery), precision, and solution stability. Three separate batches of Dapsone were successfully subjected to the desired procedures for the Genotoxic (GTI) determination and found not detected.  The corelation coefficient observed > 0.99 in linearity and 70% to 130% recovery observed in the accuracy during method validation hence method can be considered linear and accurate and can be used for testing of genotoxic impurity in Dapsone drug substances.

Keywords: Genotoxic impurities, HPLC analysis, dapsone, method development, method validation, dapson drug


How to Cite

Patel, Haresh B., Rohit H. Dave, Sandip Vadariya, Hitin Hirpara, and Trushar Patel. 2024. “Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances”. Biotechnology Journal International 28 (4):1-17. https://doi.org/10.9734/bji/2024/v28i4724.

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