Abstract

A simple, accurate, precise and highly selective reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for Pregabalin and Tapentadol. Chromatographic separation was achieved isocratically using Waters allaiance 2695 separation module, X Bridge C18 (100 x 4.6 mm, 5?) at ambient temperature. Chromatographic conditions of 1ml/min flow rate and both drugs are identified with UV visible PDA detector at 210nm. Mobile phase employed was Phosphate buffer of pH 6.85 and acetonitrile in the ratio of 55:45 which resulted better resolution and sensitivity. Developed method was validated in terms of linearity range (187.5-1125 μg/ml for Pregabalin and 175-750 μg/ml for Tapentadol), precession (correlation coefficient is less than 0.999), robustness, accuracy (recovery of Pregabalin and tapentadol were 100.77% and 99.9% respectively). The validation of proposed method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.

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