LC-UV and LC-MS evaluation of stress degradation behavior of desvenlafaxine / 药物分析学报

ABSTRACT

The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of desvenlafaxine in bulk sample and pharmaceutical dosage form in the presence of degradation products.Forced degradation studies were performed on bulk sample of desvenlafaxine as per ICH prescribed stress conditions using acid,base,oxidative and photolytic degradation to show the stability indicating power of the method.Significant degradation was observed under acidic stress condition and the degradation product formed was identified by LC-MS and a degradation pathway for drug has been proposed.Successful separation of drug from degradation products formed under stress conditions was achieved on a SymmetryShield column C18 (5 μm,250 mm × 4.6 mm,i.d.) using the mobile phase consisting of a mixture of 0.2％ (v/v) triethylamine in ammonium acetate (0.05 M; pH 6.5) and methanol using isocratic gradient.