METHOD DEVELOPMENT AND VALIDATION FOR VENLAFAXINE BY RP-HPLC METHOD

A simple, rapid and accurate stability indicating RP- HPLC method was developed for the quantitative estimation of Venlafaxine in pure and pharmaceutical formulations and the method was validated as per ICH guidelines. In this method Inertsil ODS,C18, 150 mm X 4.6 mm, 5µ column an ambient temperature of 30 ⁰ C and at a flow rate of 0.8 ml. / minute with isocratic elution was used. 20 µ L of the solution was injected and at 267nm wave length the UV detection was made. Phosphate buffer and Acetonitrile in the ratio 30:70 (v/v) was used as mobile Phase and diluent. The retention time for Venlafaxine standard (sample) was found to be 5.011 min and linearity was observed in the concentration range of 12.5 - 75 µ g with correlation coefficient of 1. The %of RSD in precision and accuracy was less than 2. The present method can be successfully used for the routine assay determination of Venlafaxine in pure form and pharmaceutical dosage forms.                 

Keywords: Venlafaxine, RP‐HPLC, Method development, Validation