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Development and validation of UV spectrophotometric method for estimation of tapentadol hydrochloride in bulk drug and pharmaceutical formulation

Ganesh B.Patil, Prashant K.Deshmukh, Pravin O.Patil, Sanjay J.Surana, Gajanan M.Marathe

A novel, simple, sensitive and rapid spectrophotometric method has been developed for estimation of tapentadol hydrochloride. The linearity of tapentadol hydrochloride was found in the range of 5-30µg/ml in water and 0.1N hydrochloric acid with correlation coefficient 0.9981 and 0.9996 respectively. The mean recovery percentage was 99.323±0.396% from water and 99.99443±1.357 from 0.1N hydrochloric acid. There were no interferences observed from the common excipients present in the formulations. The amount of drug estimated by proposed method was in excellent agreement with label claimed. The developed spectrophotometric method was simple, linear, ecoifriendly, precise, accurate and can be conveniently adopted for the routine quality control analysis of the tapentadol hydrochloride in tablet dosage form.