Development and Validation of Stability Indicating HPLC Assay Method for Determination of Tapentadol in Tablet Formulation

The purpose of the research described herein was to develop simple, precise and accurate isocratic stability indicating reversed phase HPLC assay method for determination of Tapentadol solid dosage forms. Isocratic RP-HPLC method was developed on Phenomenex Luna C8 150 4.6mm, 5μm column using mobile phase as methanol – 0.002 M potassium dihydrogen phosphate buffer pH 3.0 (60: 40 v/v) at a flow rate of 1.0 ml/min and the detection was carried out at 272 nm using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The validation element investigated showed that the method has acceptable specificity, accuracy, linearity, solution stability, precision and robustness. Index Terms Tapentadol, Stability indicating assay, Method development, Method validation