Development and validation of RP-HPLC method for simultaneous estimation of Tapentadol and Paracetamol in bulk and combined dosage form

A simple, rapid, selective, sensitive, linear, precise and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Tapentadol and Paracetamol in pharmaceutical dosage form. Separation was achieved on a reverse phase Hypersil BDS C18 (100 x 4.6 mm, 5 μ particle size) column at ambient temperature using a mobile phase consisting of Methanol: Acetonitrite: Water (50:10:40 v/v/v), at a flow rate of 1.0 ml/min. The UV detection wavelength was 273 nm and 10 μl of sample was injected. The linearity was found to be 10–60 μg/ml for Tapentadol and 65–390 μg/ml for Paracetamol with a correlation coefficient of 0.9992 and 0.9997 respectively. Retention times were found to be 2.96 min and 4.95 min for Tapentadol and Paracetamol respectively. The mean % recoveries were found to be 99.74 ± 0.32% for Tapentadol and 99.88 ± 0.17% for Paracetamol. The method was validated as per the ICH guidelines for sensitivity, linearity, accuracy and precision. The % RSD for precision, robustness and ruggedness of the proposed method was found to be less than 2%. Hence the developed method can be successfully employed for routine quality control analysis of Tapentadol and Paracetamol in pharmaceutical dosage forms.