RP-HPLC METHOD QUANTITATIVE ESTIMATION OF TAPENTADOL HYDROCHLORIDE AND ITS TABLETS

The objective was to develop and validate an easy, economical, fast, reliable, reproducible, precise and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of tapentadol hydrochloride (TAP, a mu opioid-receptor agonist, and noradrenaline reuptake inhibitor) in the bulk and pharmaceutical dosage form. The chromatographic separation was achieved by using the HPLC system equipped with a C-18(2) column (250 × 4.6 mm, Particle size 5µm) at wavelength 217 nm. The mobile phase consisting of Potassium phosphate buffer: Acetonitrile (50:50 v/v) was used in isocratic mode. The flow rate was fixed at 1.0 mL/min with a continuous run up to 5 min, while the retention time was located near about 2.5 min. In the concentration range of 60-160 µgmL^-1, the detector response was found linear with linear regressed equation Y=22791X+120122. In the assay of TAP, 99.65% of the drug was recovered. This method proved a satisfactory validation for all the parameters such as accuracy, linearity, specificity, precision, range, ruggedness, robustness, reproducibility, and peak purity assessment as per ICH guidelines. The results of the study evidenced that it is useful for the routine determination of tapentadol in the bulk and pharmaceutical dosage forms like a tablet.