Original Articles: 2011 Vol: 3 Issue: 5
Development and Validation of a Stability-Indicating HPLC Method for the Analysis of Desvenlafaxine Succinate in the Presence of its Acidic Induced Degradation Product in Bulk and Pharmaceutical Preparation
A stability- indicating High Performance Liquid Chromatography (HPLC) method of analysis of desvenlafaxine suucinate( DSV) in the presence of its acidic induced- degradation product in pure and pharmaceutical preparation had been developed and validated. The chromatographic conditions comprised of an isocratic reversed- phase separation on Discovery C18 column. Elution was carried out using acetonitrile: phosphate buffer pH 3.8 (50 : 50 v/v) as a mobile phase at a flow rate of 0.7 ml/min and UV detection at 229 nm. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range 5-100 μg/ml (r2 =0.9999). The values of slope and intercept were 34.295 and 12.564 respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria. The specificity and stability-indicating capabilities of the method was verified by subjecting DSV to acid hydrolytic stress condition. The acid degradation product was confirmed as 4-(1- cyclohexenyl-2-(dimethylamino)ethyl)phenol. Under the chromatographic condition, the degradation product was well resolved from the active pharmaceutical ingredients with significantly different retention time. Thus the proposed method was found to be stabilityindicating and can be used for routine analysis of the drug without interference of acidic degradation product. The proposed method was successfully applied for the analysis of pharmaceutical formulation. The validity of the suggested procedures was further assessed by applying the standard addition technique which was found to be satisfactory. The results were statistically analyzed and compared with those obtained by the reported method.