Development and Validation of Visible Spectrophotometric Method of Tapentadol Hydrochloride in Bulk and Pharmaceutical Dosage Form

A simple, sensitive, accurate spectrophotometric method has been developed for the estimation of Tapentadol hydrochloride in bulk and pharmaceutical formulation. The method is based on the formation of blue colored chromogen with Folin-Ciocalteu reagent in the presence of NaOH and obeys beer's law in the range of 5 - 35μg/mL exhibiting the maximum absorbance at 763nm. The limit of detection and quantification were found to be 0.76#956;g/mL and 2.33#956;g/mL respectively. The calibration curve demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.9999. The Regression Equation of the curve was Y=0.0248x-0.0436. The method was fully validated according to ICH guidelines.