Department of Quality Assurance, Parul Institute of Pharmacy and Research, Vadodara, Gujarat, India,
*Corresponding Author E-mail: prajapatikrishna12@yahoo.com
Online published on 6 May, 2013.
A simple, accurate, precise and specific spectrophotometric method has been developed for simultaneous determination of Tramadol Hydrochloride (TRA) and Diclofenac Sodium (DIC) using first order derivative spectrophotometric method by using water as a solvent. The first order derivative method in which absorption at 270.98 nm (zero cross point of TRA) was used for quantification of DIC and 248.38 nm (zero cross point of DIC) for quantification of TRA. This method follows Beer's linearity in the range of 30–90 μg/ml for TRA and 10–40 μg/ml for DIC. The mean % recoveries were found to be in the range of 99.37–100.83% and 99.61 – 100.06% TRA and DIC respectively for first order derivative method. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of TRA and DIC in their combined Tablet dosage form.
Tramadol Hydrochloride, Diclofenac Sodium, First order derivative, Analytical Method validation