MICROWAVE-ASSISTED FORCED DEGRADATION AND DEVELOPMENT OF A VALIDATED STABILITY-INDICATING RP-HPLC METHOD FOR VENLAFAXINE IN BULK AND CAPSULE FORMULATION

A stability-indicating RP-HPLC method was developed and validated for venlafaxine in bulk and capsule formulation in the presence of its degradation products, generated from forced degradation studies. Venlafaxine was subjected to forced degradation under acid, alkali, wet heat, dry heat, oxidative conditions and photolytic conditions. In addition, acid, alkali and wet heat degradation was performed using microwave oven to substitute conventional degradation technique of using heating mantle with microwave oven; provided it proved that similar degradation products were obtained under microwaveassisted degradation. Successful separation of drug from degradation products formed under forced degradation conditions was achieved on a C 18 column using 0.02 M potassium phosphate buffer (pH 3.0): Methanol (60:40 V/V) as a mobile phase at a flow rate of 1mL/min. Dual wavelength analysis was used to confirm that similar degradation behavior was observed under conventional and microwaveassisted degradation. The developed method was validated as per ICH guidelines.