A sensitive, cost-effective, reproducible HPLC method was developed and validated for the quantitative determination of genotoxic impurity methyl 4’-bromomethyl biphenyl-2 carboxylate present in telmisartan drug substance by applying the concept of threshold of toxicological concern, a limit of 18.75 µg/g was calculated based on the maximum daily dose of the drug substance. The impurity was separated on Welchrom C18 250 x 4.6 mm, 5 µm analytical column with a mobile phase consisting of the composition of 0.1% orthophosphoric acid and acetonitrile in the ratio of 30:70 v/v at a flow rate 1.5 ml/min. The effluent was monitored by UV detection at 258 nm with column temperature maintained at 40°C and the injection volume 30 μl. Validation activity was planned and completed based on the ICH guideline. The LOD and LOQ value were found to be 1.86 µg/g and 5.63 µg/g and accuracy results were well in the range 98.34 to 103.46%. The linearity curve showed the correlation coefficient of 0.999 and method very sensitive.
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