Development and Validation of Novel Spectrofluorimetric Method for Estimation of Tapentadol Hydrochloride in Bulk and in Laboratory Sample of Tablet Dosage Form

Abstract

Novel, sensitive and accurate spectrofluorimetric method has been developed and validated for estimation of tapentadol hydrochloride in bulk and in laboratory tablet dosage form. The method is based on measurement of native fluorescence of tapentadol in distilled water at 298 nm after its excitation at 273 nm. The fluorescence intensity-concentration plot was linear in the concentration range of 1- 10 μg/ml with good correlation coefficient 0.9990. The developed method was successfully applied for determination of tapentadol hydrochloride in laboratory sample of tablet dosage form. Furthermore developed method was successfully validated as per ICH guidelines in terms of, linearity (1 - 10 μg/ml), repeatability (RSD 0.39 %), precision (intra-day variation, RSD, 0.17 to 0.63 % and inter-day variation, RSD, 0.34 to 0.63 %) and accuracy (99.44 to 99.62 %). The limit of detection and quantification was found to be 0.011 and 0.034 μg/ml respectively. The developed method proved to be simple, economic and precise. Therefore proposed method can be employed for the routine quality assessment of the tapentadol hydrochloride in bulk as well as in pharmaceutical dosage forms.