Development and validation of RP-HPLC method for estimation of Tapentadol hydrochloride in its tablet dosage form.

A reversed phase high-performance liquid chromatographic method has been developed for the quantification of Tapentadol hydrochloride in tablet dosage form. The mobile phase consisting of solvent A Methanol: Solvent B Acidic water (pH 3.8 adjusted by using triethylamine and o-phosphoric acid) in ratio of (58:42 % v/v) was delivered at the flow rate of 1.2 ml/min and UV detection was carried out at 271 nm. The separation was achieved using C₁₈ reverse-phase column (250 X 4.6 mm I.D., particle size 5μm). The method was linear over the concentration range of 10-50 μg/ml. The analytical recovery obtained was 100.234%. The validation of method carried out as per ICH guidelines. 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 three different commercial brands of Tapentadol hydrochloride tablets.

Author(s): Purvi T. Bhatasana and Ashok R. Parmar

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