As per ICH guidelines three UV spectrophotometric methods viz. linear regression equation (LRE), standard absortivity (SA) and first order derivative (1D) method were developed and validate. The Lambert- Beer law was followed in range of 10-50 μg/mL. The results of all validation parameters were found to be within acceptable limits (relative standard deviation was less than 2%). The drug content in tablet dosage forms was determined by validated methods as 100.24-100.43%, 99.70-100.35% and 100.14-100.26%, respectively with acceptable standard deviation. These validated spectrophotometric methods may be successfully applied for assay, dissolution studies, bio-equivalence studies as well as routine analysis in pharmaceutical industries.
Keywords: Ramelteon, Spectrophotometric methods, Tablets