Analytical Method Development and Validation for Venlafaxine Hydrochloride: UV-Visible Spectrophotometric Estimation in Bulk and Pharmaceutical Dosage Forms

Abstract

This abstract presents the development and validation of a UV-visible spectrophotometric method for the accurate estimation of Venlafaxine HCl, a commonly prescribed antidepressant, in bulk and pharmaceutical formulations. The method utilizes purified water as the solvent, with a maximum absorbance identified at 224.60 nm. It exhibited excellent linearity within a concentration range of 5-35 μg/ml, with a high correlation coefficient (R² = 0.999) and consistent mean recovery rates between 99.00% and 100.0%. The method's cost-effectiveness and simplicity make it an ideal candidate for routine quality control. Validation was performed following ICH guidelines, ensuring reliability across parameters such as linearity, repeatability, precision, accuracy, ruggedness, and determination of LOD & LOQ. Recovery studies further confirmed the method’s applicability for the routine analysis of Venlafaxine HCl in both active pharmaceutical ingredients and commercial tablet formulations. In conclusion, this validated method provides a reliable, swift, and economical approach to the quality control of Venlafaxine HCl, making it a valuable addition to existing analytical techniques.