Abstract

HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY APPROACHES FOR METHOD DEVELOPMENT AND VALIDATION OF MODERN ANTI-DEPRESSANT DRUGS: A REVIEW

P. Sri Jyothi*, U. Bhanu Prasad, Arunabha Mallik

ABSTRACT

The global burden of depressive disorders has increased substantially, necessitating robust analytical methods for the quantification and quality evaluation of modern antidepressant drugs in bulk and pharmaceutical dosage forms. High-Performance Liquid Chromatography (HPLC) has evolved as the most versatile, accurate, and selective analytical tool for the estimation of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), atypical antidepressants, and newer multimodal agents. This review summarizes recent advances in HPLC method development and validation strategies applied to these drugs, emphasizing chromatographic conditions, forced-degradation studies, stability-indicating method development, green analytical approaches, and Quality by Design (QbD)-enabled optimization. A detailed literature review highlights more than two decades of HPLC methods for antidepressants including fluoxetine, sertraline, paroxetine, escitalopram, venlafaxine, duloxetine, bupropion, Vortioxetine, and Vilazodone. Method validation parameters such as linearity, precision, accuracy, robustness, LOD, LOQ, and system suitability are critically reviewed. The discussion compares analytical trends, limitations, and gaps in published work, with recommendations for future research focused on green solvents, miniaturized columns, and AQbD philosophies. This review concludes that modern HPLC approaches remain indispensable for antidepressant estimation, but emerging analytical technologies and regulatory emphasis on QbD demand continued innovation.

Keywords: HPLC; antidepressants; SSRIs; SNRIs; Method Development; Method Validation; QbD; Stability-Indicating Methods; Pharmaceutical Analysis; Green Analytical Chemistry.