Development and Validation of RP-HPLC Method for Simultaneous Estimation of Paracetamol and Tramadol Hydrochloride

A simple and rapid RP-HPLC method has been developed for the simultaneous estimation of paracetamol and tramadol hydrochloride. The chromatographic analysis was carried out on an Enable C18 column (250×4.6 mm i.d., 5μm) at ambient room temperature. The mobile phase used was a 60: 40 (v/v) mixture of 10 mM potassium dihydrogen orthophosphate buffer at pH 3: Acetonitrile. Mobile phase flow rate was maintained at 1 ml/min with a run time of 5 minutes and eluents were monitored at 215 nm. The retention times of paracetamol and tramadol hydrochloride were 3.1 seconds and 3.4 seconds respectively. The peaks were sharp, symmetrical and adequately resolved with sufficient theoretical plate count indicating the system suitability. The calibration curves were found to be linear over the concentration ranges 20 μg/mL to 100 μg/mL. The limit of detection of paracetamol and tramadol hydrochloride was 6.19 μg/mL and 5.56 μg/mL respectively. The method validation was carried out and the parameters observed were within acceptable limits.