Abstract

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

Author(s): 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