A simple, fast, and new ion pair chromatographic method was developed and validated, for the simultaneous estimation of Tramadol hydrochloride and paracetamol in pharmaceutical formulations. The developed method uses acetonitrile: 5% sodium lauryl sulphate: methanol in the ratio of 45:15:40 v/v with flow rate of 1mL /minute. The optimum separation was achieved in less than 5 minutes using WATERS Symmetry C18 column (250mm X 4.6mm, 5µm, i.d.) detection was carried out using UV detector, measuring the response at 217nm. Beer’s law was obeyed in the concentration range of 20-187.5µg/mL for tramadol and 20-1625 µg/mL for paracetamol, with a detection limit of 4ng/mL for tramadol and 5ng/mL for paracetamol, and a quantitation limit of 15ng/mL for tramadol and 16ng/mL for paracetamol. Intra-day and Inter-day precision and accuracy of the methods have been established according to the current ICH guidelines. The regression co-efficient (r2) value for tramadol and paracetamol was found to be 0.9998 and 0.9996 respectively. The average recovery for tramadol was 100.03% and 100.28% for paracetamol. No interferences were observed from the excipients. The proposed method was found to be accurate, precise and rapid for the simultaneous estimation of tramadol and paracetamol.
Cite this article:
Jane Fatima Mary Titus, A Thenmozhi, D Sridharan. An Ion-Pair Chromatography Method for Simultaneous Estimation of Tramadol and Paracetamol in Combined Tablet Dosage Form. Research J. Pharm. and Tech. 3(1): Jan.-Mar. 2010; Page 179-182.