A new stability indicating RP-UFLC method for the estimation of Tapentadol in tablet dosage forms

Abstract

Tapentadol is used for the treatment of hypertension and other cardiovascular failures. A new stability indicating RP-UFLC method has been proposed for the estimation of Tapentadol in tablet dosage forms. A mixture of 10 mM ammonium acetate: acetonitrile (48:52) was chosen as mobile phase (Isocratic mode) with flow rate 0.8 mL/min (Detection wavelength 273 nm). Shimadzu Model UFLC system with PDA detector and X Bridge C18 Column was used for the study. Tapentadol obeys Beer-Lambert’s law over the concentration range 0.5-200 µg/mL with linear regression equation y = 11991x + 4407 (R² = 0.9999). The LOQ and LOD were found to be 0.4871 µg/mL and 0.1593 µg/mL. Stress degradation studies were performed such as acid hydrolysis, alkaline hydrolysis, thermal treatment and oxidation according to the ICH guidelines. The proposed UFLC method has validated and found to be simple, precise, accurate, robust and is very much useful for the analysis of Tapentadol tablets.