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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Stress Degradation Study of Tapentadol Hydrochloride by Stability Indicating HPLC Method

G R Shendarkar & P S Tarte

Introduction: Tapentadol hydrochloride was degraded under different stress conditions i.e. hydrolysis, photolysis, oxidation and thermal degradation. The samples so generated were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the Tapentadol hydrochloride. The drug was well separated from degradation products using a reversed-phase (C-18) column and a mobile phase comprising of Acetonitrile: phosphate buffer 0.05M pH3.2 (40:60 v/v). Other HPLC parameters were: flow rate, 1 mL/min; detection wavelength, 272 nm; and injection volume 20 l. The method was validated for linearity, precision, accuracy and ruggedness. Results obtained after validation study, indicating that the proposed single method allowed analysis of Tapentadol hydrochloride in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of stability of the drug in commercial pharmaceutical dosage form. 

 

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