Determination of Tapentadol Hydrochloride in Tablets by Three New Validated Spectrophotometric Methods

Abstract

Three UV spectrophotometric methods viz. linear regression equation (LRE), standard absorptivity (SA) and first order derivative (FOD) method were developed and validated according to ICH guideline. The methods were linear in the range of 10-50 μg/mL and validated methods were successfully applied for determination of tapentadol hydrochloride content in tablet dosage forms in the range of 100.42-100.64%, 100.31-100.54% and 100.10-100.59%, respectively. The standard deviation for all the methods was found to be less than one unit (0.45-0.83). The validated spectrophotometric methods may be successfully applied for assay, dissolution studies, bio-equivalence studies as well as routine analysis in pharmaceutical industries.