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Development and Validation of RP-HPLC Method for Quantitative Analysis of Tramadol in Pure and Pharmaceutical Formulations

R. B. Desireddy, P. Jitendra Kumar, A. Sai Chand, P. Lakshmana Rao, Ch. Kranthi Kumar, S. Hari Kumar and T. Kalyan Chakravarthy

A validated simple, sensitive, specific and precise RP-HPLC method was developed for the determination of Tramadol in pure and pharmaceutical formulations. Method was carried on Zodiac C18 column (250 mm × 4.6 mm × 5 µ particle size) using Methanol: Acetonitrile: water (15 : 60 : 25) as mobile phase. Detection was carried out by U.V. at 218 nm. The proposed method obeyed linearity in the range of 60-200 µg/mL and met all specifications as per ICH guidelines. Statistical analysis revealed that this method can be used in routine quality control studies of Tramadol in pure and its formulations