A simple, accurate, rapid, sensitive and precise RP-HPLC method has been developed for estimation of Tapentadol hydrochloride in tablet dosage form using PDA detector. A Reverse phase Develosil ODSUG c18 column (150mm × 4.6 mm I.D., × 5µ particle size) with the Mobile phase consisting of Acetonitrile and Triethyl amine buffer 40:60(v/v) [PH 3±0.02 adjusted with orthophosphoric acid] was used. The Flow rate was 1.00 ml/min and the effluents were monitored at 215nm, and the Injection volume was 10µl. The separation was performed at ambient temperature. Retention time of Tapentadol hydrochloride was found to be 5.3 minutes respectively. The Linearity of the method was found to be 50-150µg/ml. The Correlation co-efficient of Tapentadol hydrochloride was found to be 0.9997. The %Recoveries of Tapentadol hydrochloride were found to be 99.3%. The system suitability parameters such as Theoretical plates and Tailing factor were found to be 2835, 1.563. Hence the proposed method was successfully applied for routine quality control analysis of Tapentadol hydrochloride in tablet dosage form. This method was validated according to ICH guidelines.
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