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Stability indicating liquid chromatographic method for the estimation of desvenlafaxine in pharmaceutical dosage form

Shah Dimal A. (Indukaka Ipcowala College of Pharmacy, Beyond GIDC, Gujarat, India)
Nakrani Riddhi S. (A.R. College of Pharmacy, Gujarat, India)
Baldania Sunil L. (A.R. College of Pharmacy, Gujarat, India)
Chhalotiya Usmangani K. (A.R. College of Pharmacy, Gujarat, India)
Bhatt Kashyap K. (A.R. College of Pharmacy, Gujarat, India)

A simple, sensitive, precise and stability indicating liquid chromatographic method has been developed for the estimation of desvenlafaxine succinate in pharmaceutical dosage form. A Hypersil C-18, 5 mm column with a mobile phase containing 0.05 M potassium dihydrogen phosphate: methanol (60:40 v/v) pH 7 was used. The flow rate was 1.0 mL/min and effluents were monitored at 226 nm. The retention time of desvenlafaxine was 7.4 min and the method was linear in the range of 0.1-20 µg/mL. Desvenlafaxine stock solution was subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The drug was found to be susceptible to base hydrolysis and developed method was found to give good separation between the pure drug and the degraded product. The method was successfully applied to the estimation of desvenlafaxine in tablet dosage forms.

Keywords: desvenlaflaxine, degradation, reversed phase liquid chromatography, validation