RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TAPENTADOL HYDROCHLORIDE IN ITS SOLID DOSAGE FORM

The present paper describes simple and sensitive, reversed phase high performance liquid chromatography (RP-HPLC) method developed for the determination of tapentadol hydrochloride in bulk and in its tablet dosage form. Chromatographic separation was achieved by using phenomenex C18 column, 250×4.6 mm, 5 μm as stationary phase. Mixture of acetonitrile: water (80:20 V/V) was used as the mobile phase and the pH was adjusted into 7.0 using orthophosphoric acid, at a flow rate of 0.7 mL/ min. Tapentadol standard shows maximum absorption in UV at 272 nm. The method was linear over the concentration range of 5-25 μg/mL. The method was validated statistically and recovery study was performed as per ICH guidelines. The analytical recovery obtained was 98-119%. As per validation data it was found that method is specific, robust and precise within the described concentration range. The described RP-HPLC method was successfully employed for the analysis of a commercial brand of tapentadol hydrochloride tablets.