A Novel Approach using Hydrotropic Solubalization Technique for Quantitative Estimation of Entacapone in Bulk Drug and Dosage Form

Purpose: Analysis of drug utilized the organic solvent which are costlier, toxic and causing environment pollution. Hydrotropic solution may be a proper choice to preclude the use of organic solvents so that a simple, accurate, novel, safe and precise method has been developed for estimation of poorly water soluble drug Entacapone (Water Solubility-7.97e-02 g/l). Methods: Solubility of entacapone is increased by using 8M Urea as hydrotropic agent. There was more than 67 fold solubility enhanced in hydrotropic solution as compare with distilled water. The entacapone (ENT) shows the maximum absorbance at 378 nm. At this wavelength hydrotropic agent and other tablet excipients do not shows any significant interference in the spectrophotometric assay. Results: The developed method was found to be linear in the range of 4-20 μg/ml with correlation coefficient (r2) of 0.9998. The mean percent label claims of tablets of ENT in tablet dosage form estimated by the proposed method were found to be 99.17±0.63. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Conclusion: As hydrotropic agent used in the proposed method so this method is Ecofriendly and it can be used in routine quantitative analysis of drug in bulk drug and dosage form in industries.