Vinod Acharya Author

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Application of an LC-MS/MS Method in Quantification of Hexyl Chloroformate Content in Dabigatran Etexilate Mesylate

Author(s):

Rakesh Kumar Yadav, Jayvant Harlikar, Jaidatta Deshmukh, Chetan M. Bhalgat, Dipak Thange, Hemant Birari, Manish Gangrade, Srinivas V Pullela and Vinod Acharya

 Application of an LC–MS/MS Method in Quantification of Hexyl Chloroformate Content in Dabigatran Etexilate Mesylate

Abstract

A selective and sensitive liquid chromatography–mass spectrometry (AB SCIEX QTRAP 5500) method was developed for quantitative determination of genotoxic impurity, hexyl chloroformate, in drug substance. The method was developed by derivatizing the hexyl chloroformate (HCF) to complex compound hexyl benzylcarbamate (HBC) by reaction with benzylamine. This method provided good sensitivity for quantification of hexyl chloroformate at a concentration of 10 ppm in 10 mg/mL... view more»

DOI: 10.4172/2325-9604.1000154

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