Determination of the Related Substances of Cinacalcet Hydrochloride by HPLC

OBJECTIVE To establish an HPLC method for determining the contents of the related substances of cinacalcet hydrochloride. METHODS The condition of detection were: Waters C₁₈ column (250 mm×4.6 mm, 5μm), the gradient mobile phase consisted of acetonitrile and 10 mmol·L^-1 potassium dihydrogen phosphate (adjust with 2 mol·L^-1 potassium hydroxide to pH 6.5) with a flow rate of 1.0 mL·min^-1, the UV detection wavelength was 210 nm. RESULTS The resolution of cinacalcet hydrochloride and relate substances was good. The calibration curves were linear in the range of 0.228 6-4.572 μg·mL^-1 for Imp1(r=1.000); the calibration curves were linear in the range of 0.239 6-4.791 μg·mL^-1 for Imp2(r=1.000); the calibration curves were linear in the range of 0.274 1-5.481 μg·mL^-1 for Imp3(r=1.000); the calibration curves were linear in the range of 0.102 9-2.059 μg·mL^-1 for Imp4(r=0.999 8). The average recoveries of Imp1, Imp2, Imp3 and Imp4 were 99.3%, 98.9%, 99.0% and 100.4% respectively; the RSD were 1.8%, 2.9%, 1.7% and 1.7% respectively. CONCLUSION The method is simple, accurate, reliable and can be used for the quality control of the related substances of cinacalcet hydrochloride.