RP-HPLC Method for Simultaneous Estimation of Tramadol HCl and Paracetamol Bulk Drug and Its Combined Dosage Form

This work is concerned with application of simple, accurate, precise and highly selective reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Tramadol HCl and Paracetamol in combined dosage form. Chromatographic separation was achieved isocratically at room temperature on phenomenex C₁₈ column (250 x 4.6 mm) with a mobile phase composed of 5% Tri-fluoroaceticacid in water: Acetonitrile: Methanol in the ratio of 70:20:10% v/v/v at flow rate of 1.0 ml/min. Detection is carried out using a UV detector at 254 nm. The retention time of Tramadol HCl and Paracetamol was found to be 3.890± 0.5 min and 1.990± 0.5 min. respectively. The method was found to be linear in the range of 0.1–10 μg/ml with mean recovery of 98.96% for Tramadol HCl and 99.11% for Paracetamol. The correlation coefficients for all components are close to 1. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of Tramadol HCl and Paracetamol in routine analysis.