A simple, specific, accurate, precise and reproducible Ratio spectra derivative spectrophotometric method has been developed and validated for the simultaneous estimation of Tramadol hydrochloride (TRM) and Aceclofenac (ACE) in their combined dosage form. The ratio derivative spectroscopic method involves measurement of first derivative amplitude of ratio spectra at 281.80 nm for TRM and 285.40 nm for ACE as two wavelengths for estimation. Beer's law is obeyed in the concentration range of 5-65 and 4-36 μg/mL for TRM and ACE, respectively. LOD values for TRM and ACE are found to be 0.467 μg/mL and 0.45 μg/mL, respectively. LOQ values for TRM and ACE are found to be 1.417 μg/mL and 1.373 μg/mL respectively. The results of analysis have been validated statistically and recovery studies carried out in the range 80-120% to confirm the accuracy of the proposed method. The method was validated as per International Conference on Harmonization (ICH) guideline in terms of accuracy, precision, linearity, limits of detection, limits of quantitation. This method has been successively applied to tablet formulation and no interference from the sample mixture’s excipients was found.
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