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