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 relief of moderate to severe pain. It is an opioid analgesic, acts dual mechanism as receptor agonist norepinephrine reuptake inhibitor. The present research work aimed develop accurate, precise, rapid RP-HPLC method subsequently validates according International Conference on Harmonization (ICH) guidelines determination Hydrochloride.
 Methods: analyzed using High-Performance Liquid Chromatography. Better separation drug achieved a Symmetry C18 column (150x4.6mm, 3.5μm) with mobile phase consisted mixture Orthophosphoric acid (0.1% in HPLC water) acetonitrile ratio 30:70 v/v at flow rate 1 ml/min, detection wavelength 219nm PDA detector.
 Results: retention time found be 3.747 ± 0.127 min. linear range 10-200 ug/ml correlation coefficient (r2) 0.9991. LOD LOQ were calculated 0.1 1μg/ml respectively. precision system estimated results % RSD values, which within limits. Recovery 100.1%, confirms efficiency method.
 Conclusion: developed validated standard ICH guidelines. can used analysis both tapentadol hydrochloride bulk formulations.