Abstrato

Determination of 3-Trifluoromethyl benzaldehydegenotoxic impurity in Cinnacalcet drug substances

S.Senthil kumar, Sushil jaiswal,V.Srinivasarao

A new simple, sensitive HPLC method developed and validated for the determination of 3- Triflouromethyl benzaldehyde in Cinacalcet. 3- Triflouromethyl benzaldehyde was separated on Inertcil ODS-3V analytical column with water and acetonitrile used as mobile phase at a flow rate 1.0ml/min. The effluent was monitored by UV detection at 240nm. Column temperature maintained at 35ºC, injection volume 25µl. Calibration plots were linear in the range of LOQ to 150% level and LOQ and LOD were 0.06 and 0.02.The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of 3- Triflouromethyl benzaldehyde in Cinnacalcet