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

Abstract

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.