ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TRAMADOL IN BULK AND ITS FORMULATIONS BY UV-SPECTROSCOPY

Abstract

The present study describes a simple, accurate, precise and cost-effective UV-Spectrophotometric method for the estimation of Tramadol Hydrochloride, an analgesic, in bulk and pharmaceutical dosage form. The drug was dissolved in double distilled water (used as solvent). Because of cost-effective and minimal maintenance, UV-spectrophotometry is always preferred at small scale industries. The λmax or the absorption maxima of the pure drug was found to be 271nm. A linear response was observed in the range of 30 to 150μg/ml with the regression co-efficient of 0.999. The method was validated for different parameters as per the ICH (International Conference for Harmonization) guidelines. This method can be used for the determination of Tramadol Hydrochloride in quality control of formulation without interference of the excipients. The developed method is simple, precise, rugged, robust, and economical. The method can be used for routine analysis of tramadol from its tablet formulation. The described methods can be readily utilized for analysis of pharmaceutical formulation.