Quantification of Potential Impurities by a Stability Indicating Hplc Method in Desvenlafaxine Succinate Monohydrate Active Pharmaceutical Ingredient

A sensitive, selective and stability indicating reverse phase method has been developed for the quantitative determination of potential impurities of Desvenlafaxine succinate monohydrate active pharmaceutical ingredient. Efficient chromatographic separation was achived on C8 stationary phase. Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. Major degradation of the drug substance was found to occur under oxidative stress conditions to form desvenlafaxine N-oxide. The method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. Regression coefficient value was greater than 0.999 for Desvenlafaxine succinate monohydrate impurities. Detection limit of impurities were in the range of 0.002-0.016% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 94.65% and 101.05% for all impurities.