Development and validation of hplc method for estimation of tapentadol and its process-related impurities

摘要

To develop a simple, novel, sensitive, precise and specific HPLC method for the determination of Tapentadol hydrochloride and its process-related impurities in bulk drugs. The chromatographic separation was achieved on Inertsil ODS 3V (250 x 4.6 mm), 5μm column was used with photo diode array detector (PDA) and variable wavelength detector (VWD) as a stationary phase using acetonitrile: ammonium phosphate buffer (pH 6.3 adjusted with tryethylamine) as mobile phase at detection wavelength 219 nm in Gradient mode at a flow rate of 1.0 ml/min.