Method Development and Validation for Simultaneous Estimation of Tapentadol and Paracetamol in the Bulk and Pharmaceutical Dosage Form by UV Spectrophotometry

A simple, rapid, accurate and precise UV Spectrophotometric method was developed for the simultaneous estimation of tapentadol (TAP) and paracetamol (PCM) in the pharmaceutical dosage forms. This method utilizes 0.1N hydrochloric acid (HCl) as solvent. Absorption maxima (
max) of tapentadol and paracetamol was found to be 272.5 nm and 244.0 nm respectively, but we selected 257 nm for paracetamol, because at this wavelength tapentadol is showing linear absorbance values. Linearity was observed in the concentration range of 4-28 µg/ml for both the drugs. The R2 value was found to be 0.9991 and 0.9986 for tapentadol and paracetamol respectively. The method was validated statistically and by recovery studies. The mean percentage recovery was found to be between 95% - 105% for tapentadol and paracetamol.