A VALIDATED METHOD FOR THE DETERMINATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION BY DENSITOMETRIC ANALYSIS

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.