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A Simple Validated UV Spectroscopic Method for the Determination of Tapentadol in Bulk and Its Tablet Dosage Forms

B. Mohammed Ishaq1*, Dr. K. Vanitha Prakash2, Dr. Hindustan Abdul Ahad1Shaik Muneer1, H. Ruksana1, E. Sateesh1 
1Department of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur-515001, A. P, India
2SSJ College of Pharmacy, Gandipet, Hyderabad, A.P. India
Received: 10 April 2014, Accepted: 18 May 2014, Published Online: 18 July 2014

Tapentadol (TAP) is a novel opioid pain reliever drug that is unusual in its possession of dual mechanism of action (mu opioid-receptor agonist and noradrenaline reuptake inhibitor), this feature makes the active ingredient an attractive potential progenitor of a new pharmacological class. The present research work discusses the development and validation of a UV spectrophotometric method for TAP. Simple, accurate, precise and cost efficient spectrophotometric method has been developed for the estimation of TAP in bulk and its tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 272 nm in water. The mean percentage recovery of TAP was found to be in range 99.860 %. Beers law was obeyed in the concentration range of 15-120 μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0064x + 0.0224 with R² = 0.9978 was obtained. Validation was performed as ICH guidelines for Linearity, accuracy, precision, LOD and LOQ. The proposed method may be suitable for the analysis of TAP in bulk and tablet formulation for routine quality control purposes.
Keywords: Tapentadol, mu opioid, UV spectrophotometric.

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