Low-Level Quantitation of Formaldehyde in Drug Substance by HPLC–UV

摘要: Formaldehyde has been highlighted as potential genotoxic impurity (GTI). Trace-level quantification of GTIs in drug substances requires sensitive, precise and accurate analytical methodologies for their estimation control. Analysis formaldehyde is very challenging due to its properties namely volatility, high polarity, low molecular weight over above the absence chromophore. This article presents a validated HPLC–UV method which sensitive active pharmaceutical ingredient. As does not possess chromophore, developed HPLC involves derivatization with 2,4-dinitrophenylhydrazine. Using this method, detection quantitation limits achieved are 0.5 1.5 ppm, respectively. The calibration curve was linear concentration range 1.5–20 ppm. found be proposed successfully applied estimate content scale-up batches bulk drug.