Back Cover: Development and validation of HPLC methodology for quantitative estimation of Efinaconazole in topical pharmaceutical formulation prepared in‐house for the treatment of onychomycosis

Abstract

DOI: http://doi.org/10.1002/sscp.202000050 The cover picture shows an orthogonal approach for method development and validation of three potential halo alkyl alcohol genotoxic impurities in miglitol drug substance by fast gas chromatography–mass spectrometry. The chloro ethanol/bromo ethanol/iodo ethanol is a key starting material (KSM) in miglitol drug substance synthesis. As per ICH M7, it is a potential genotoxic impurity (PGI), it should show cut‐off in miglitol drug substance. The developed and validated FGC‐MS quantitative method for chloro ethanol, bromo ethanol and iodo ethanol in miglitol drug substance are specific, accurate, precise, linear, robust and rugged at 2.0 ppm limit quantitation level and they can be detected up to 0.7 ppm.