Abstract
A simple, rapid and sensitive RP-HPLC-PDA method was developed and validated as per ICH guidelines for the analysis of tapentadol in bulk as well as in tablet formulation. The RP-HPLC isocratic method was developed using a column LC-GC Qualisil BDS C-18 (250 mm × 4.6 mm × 5 μm) and methanol - potassium dihydrogen phosphate buffer (pH 7.0) mixture (80:20, v/v) as a mobile phase. The flow rate was retained at 1 ml min-1 and the response was detected at 274 nm. Robustness of the developed method was evaluated using two experimental designs (central composite design and response surface methodology). The effect of factors such as mobile phase composition, flow rate and pH of mobile phase were studied.
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