NEW RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND TRAMADOL HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Abstract

The present work was focused on developing a new RP-HPLC method for the simultaneous estimation of paracetamol and tramadol hydrochloride in bulk and tablet dosage form and to validate it as per ICH and USP guidelines. The method involves use of water and acetonitrile in 9:1 ratio as mobile phase pumped at a rate of 1ml/min. The optimum wavelength selected for monitoring was 268nm. C18 column (4.6mm×250mm) of 5µ particle size was used as stationary phase. The method was finally validated, and parameters were reported. The system suitability parameters passed in which the asymmetric factors for Paracetamol and Tramadol were 1.54 and 1.09 respectively. Linearity ranges were found to be 20 to 100µg/ml with a correlation coefficient of 0.998. Accuracy studies reported a mean recovery of 98.7% for both the drugs. Faster retention times (1.1min and 4.1min) make the method simple and economic. Thus a validated and sensitive RP-HPLC method was developed for simultaneous estimation of Paracetamol and tramadol in bulk and tablet dosage form.