Simultaneous Estimation of Multicomponent Drugs by HPLC: A Comprehensive Review on Method Development and Validation

The rapid growth of fixed-dose combinations (FDCs) in the pharmaceutical industry necessitates precise analytical methods for the simultaneous estimation of multiple active ingredients. High-Performance Liquid Chromatography (HPLC) is the preferred technique for these analyses due to its high selectivity, sensitivity, and reproducibility. This review provides a comprehensive overview of systematic HPLC method development and validation, emphasizing alignment with ICH (Q14, Q2(R2)), FDA, and WHO regulatory standards. The article covers core principles such as stationary and mobile phase selection, detection systems, and experimental design approaches like Quality by Design (QbD), One-Factor-At-a-Time (OFAT). Key validation parameters— including specificity, linearity, accuracy, and precision—are discussed to ensure analytical robustness. This article provides a structured roadmap for developing robust, validated methods essential for the quality control and lifecycle management of multicomponent pharmaceuticals.