Stability Indicating RP-HPLC Method for Simultaneous Estimation of Acetaminophen and Tramadol Hydrochloride in Tablet Dosage Form

S. Pavani, V. Hari Baskar*, B. Prathap, Ramesh Dhani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur (V&P), Muthukur (M), SPSR Nellore, A.P, India

ABSTRACT
A simple, Accurate, rapid and precise method was developed for the simultaneous estimation of the Acetaminophen and Tramadol hydrochloride in Tablet dosage form. The chromatogram was run through. Spurcil, column (4.6 x 150mm, 5µ).Mobile phase containing0.1%OPA: Acetonitrile is taken in the ratio 30:70 was pumped through the column at a flow rate of 1 ml/min. The buffer used in this method was 0.1%OPA buffer. The temperature was maintained at 25°C. Optimized wavelength selected was 280nm. The retention time of Acetaminophen and Tramadol hydrochloride were found to 1.965 min and 3.826. % RSD of Acetaminophen and Tramadol hydrochloride were found to be 0.7 and 0.2 respectively. % Recovery was obtained at 100.14% and 99.92 for Acetaminophen and Tramadol hydrochloride respectively. LOD, LOQ values obtained from regression equations of Acetaminophen and Tramadol hydrochloride and were 3.03, 10.02 and 3.00, 10.00 respectively. The accuracy and reliability of the method were assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2 for Acetaminophen and Tramadol hydrochloride), accuracy and specificity, in accordance with ICH guidelines. This method has been successively applied to the pharmaceutical formulation and was validated according to ICH guidelines.
Key words: Acetaminophen and Tramadol hydrochloride, RP-HPLC.