RP-HPLC Method Development and Validation of Tapentadol Hydrochloride in Bulk and Pharmaceutical Formulations

Objective: Tapentadol Hydrochloride was approved (November 2008) by the United States Food and Drug Administration for the relief of moderate to severe pain. It is an opioid analgesic, acts by dual mechanism as opioid receptor agonist and norepinephrine reuptake inhibitor. The present research work was aimed to develop an accurate, precise, and rapid RP-HPLC method and subsequently validates the method according to the International Conference on Harmonization (ICH) guidelines for the determination of Tapentadol Hydrochloride. Methods: Tapentadol Hydrochloride was analyzed by using High-Performance Liquid Chromatography. Better separation of the drug was achieved by using a Symmetry C18 column (150x4.6mm, 3.5 mu m) with the mobile phase consisted of a mixture of Orthophosphoric acid (0.1% of Orthophosphoric acid in HPLC water) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 1 ml/min, and the detection was at the wavelength of 219nm using a PDA detector. Results: The retention time of Tapentadol Hydrochloride was found to be 3.747 +/- 0.127 min. The method was found to be linear in the range of 10-200 ug/ml with a correlation coefficient (r(2)) of 0.9991. The LOD and LOQ of the method were calculated to be 0.1 and 1 mu g/ml respectively. The method precision and system precision was estimated and the results were calculated as % RSD values, which were found to be within the limits. Recovery of Tapentadol Hydrochloride was found to be 100.1%, which confirms the efficiency of the method. Conclusion: The developed RP-HPLC method was validated using standard ICH guidelines. The developed method can be used for the analysis of both tapentadol hydrochloride bulk and formulations.