Development and Validation of Newer Analytical Methods for the Estimation of Tapentadol Hydrochloride in Bulk and in Tablet Dosage form by UV - Visible Spectrophotometry and Hptlc.

The present work, aims to develop a simple, precise and accurate methods for the estimation of Tapentadol Hydrochloride in bulk and in pharmaceutical dosage form by using UV spectroscopy, visible spectrophotometry and HPTLC and to validate the developed methods. Survey on Literature: The survey on literature performed for Tapentadol Hydrochloride for their physiochemical properties, solubility, pharmacology and analytical techniques. So this basic information gives notation for newer method development. Method Development: Identification of drug by its melting point and IR spectral studies, Selection of suitable solvent for quantitative extraction of drug present in the formulations. The solvent should be readily available, economical and of analytical grade for UV-spectroscopy, visible spectrophotometry and HPTLC. The solvent should not interact with the compound of interest and its structural characteristics, Selection of method for analysis, depending on the spectral characteristics of the drug. Selection of suitable wavelength for rapid and accurate simple UV and Difference spectrophotometric methods development. Development of simple, cost effective and accurate visible spectrophotometric methods. Development of simple and accurate HPTLC method. Analysis of marketed formulations. Validation of developed analytical methods. Statistical analysis of developed analytical methods. the developed methods were validated according to ICH guide lines, and the results obtained in the validation (Accuracy, Precision, Repeatability, Intermediate Precision, Specificity, Detection Limit, Quantitation Limit, Linearity and Range) are within the limits according to ICH guide lines. Hence, it is suggested that the proposed UV-Visible spectrophotometric methods and HPTLC method can be effectively applied for the routine quality control analysis of Tapentadol Hydrochloride in bulk and in its tablet dosage form