Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF DESVENLAFAXINE SUCCINATE MONOHYDRATE IN TABLET DOSAGE FORM

*Ratna Kailas Pingle, Kishor Salunkhe, Sanjay Chaudhari

Abstract

The objective of this work was to develop and validate simple, rapid and accurate chromatographic method for determination of Desvenlafaxine succinate in solid dosage form. This RP-HPLC method was based on Reversed Phase High Performance Liquid Chromatography, on Kromasil C-18, (250 mm × 4.6 mm, 5.0 μm) , using Acetonitrile: Ammonium Phosphate buffer (pH 3.0) (70:30 v/v) as the mobile phase, at a flow rate of 1 mL/min at ambient temperature. Quantification was achieved by UV detection at 220 nm over a concentration range of 20-160 μg/mL for Desvenlafaxine succinate. The mean retention time for Desvenlafaxine succinate was found to be 2.44 min. The amount of Desvenlafaxine succinate estimated as percentage label claim was found to be 99.67.

Keywords: RP-HPLC, Desvenlafaxine succinate, marketed formulation.