Dr. Narasimha S. Lakka, PhD, C. Kuppan, Poornima Ravinathan
Jan 6, 2022
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Influential Citations
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Journal
Biomedical chromatography : BMC
Abstract
2-(2-Chloroethoxy)ethanol (CEE) belongs to the so-called cohort of concerns which were classified as a highly potent mutagenic carcinogen by the World Health Organization. CEE is widely used in the synthesis of essential anti-histamine drug hydroxyzine. Besides, it is used as primary solvent in the dyes, nitrocellulose, paints, inks and resins. Owing to its potential genotoxicity, an efficient liquid chromatography-tandem mass spectrometry method was developed for the quantitative estimation of CEE traces in an active pharmaceutical ingredient and in tablet dosage forms of hydroxyzine-free base. The chromatographic separation was achieved on C18 column using a gradient elution mode with a binary solvent system (ammonium formate and methanol). Mass detection was performed for the CEE using a positive mode with selected ion monitoring technique at m/z value of [M+NH4 ]+ . The developed method was validated as per the ICH guideline, the quantitation limit, linearity and recoveries were found to be 0.56 ppm, 0.56 ~ 7.49 ppm (r2 > 0.9985) and 93.6 ~ 99.3%, respectively. The proposed method was highly compatible and was worked effectively to estimate the CEE traces in different stages of drug synthesis and in tablet dosage forms of hydroxyzine for the routine and stability testing.