Original Articles
S Senthil Kumar, Ritesh Kumar
Abstract
A sensitive, cost-effective, reproducible HPLC method was developed and validate for the quantitative determination of genotoxic impurity methyl 2-amino-3-nitrobenzoate present in candesartan cilexetil drug substance by applying the concept of threshold of toxicological concern, a limit of 46.88 μg/g was calculated based on the maximum daily dose of the drug substance. The impurity was separated on Kromasil C18 250 x 4.6 mm, 5 μm analytical columns with a mobile phase consisting of the buffer pH 3.0 and acetonitrile with the gradient program at a flow rate 1.0 ml/min. The effluent was monitored by UV detection at 235 nm with column temperature maintained at 30 °C and the injection volume 10 μl. Validation activity was planned and completed based on the ICH guideline. The LOD and LOQ value were found to be 1.55 μg/g and 4.70 μg/g and accuracy results were well in the range 99.02 to 102.68 %. The linearity curve showed the correlation coefficient of 0.9999 and method very sensitive.