Abstract

A new validated liquid chromatographic method for the determination of impurities in cinacalcet hydrochloride

Author(s): Ashok Sigala, CH V Raghunath Babu, M.Satish Varma, G.Balaswamy

A reversed-phase liquid chromatographic method has been developed and subsequently validated for the determination of cinacalcet Hydrochloride and its process-related impurities. The separation was achieved onAce C18 (250 x 4.6mm, 5) column using amobile phase consisting of potassiumdihydrogen phosphate buffermixed with 1.0ml of triethylamine, adjusted to pH 6.0 with phosphoric acid and acetonitrile under gradient conditions. The flow rate was maintained at 1.2mLmin-1 and UVdetectionwas performed at 223 nm. Themethod described is linear over the ranges of 0.028 to 0.68 g mL-1 and 0.024 to 0.68 g mL-1 for impuritiesAand B, respectively. The method is precise and accurate with%RSD value less than 1.0%and the recovery of impuritieswere in the range of 96 – 102 %. The method is simple, selective and stability indicating and is useful in the quality control of bulk drug manufacturing.