Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE SIMULTENEOUS ESTIMATION OF PARACETAMOL AND TRAMADOL IN COMBINE DOSAGE FORM

*Mayur S. Patil, Sachin S. Rane, Milind E. Chaudhari, Prof. (Dr.) Rajesh Y. Chaudhari, Prof. (Dr.) Vijay R. Patil

Abstract

A simple, robust, precise, UV spectroscopic method has been developed for the simultaneous estimation of paracetamol and tramadol in bulk and capsule dosage forms. In this paper the estimation of those drugs was carried out by simultaneous equation method. This method is based on measurement of absorption at 243nm and 272nm i.e, λmax of paracetamol and tramadol respectively. The linearity observed for paracetamol is in the range of 10-50 μg/ml and for tramadol is in the range of 5-25 μg/ml. The accuracy of methods was assessed by recovery studies and was found to be within the range of 99%-101% for both paracetamol and tramadol. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceutical formulations with no interference from any excipients and diluents. The results were validated as per ICH guidelines.

Keywords: Paracetamol, Tramadol, Simultaneous estimation Method, ICH, Validation.