Drug manufacturing has advanced rapidly, leading to the creation of complex, multi-component dosage forms that improve both treatment outcomes and patient adherence. Ensuring the safety, chemical integrity, and potency of these formulations requires highly dependable testing techniques. Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) continues to be the primary tool for pharmaceutical quality control because of its unmatched resolving power and day-to-day reliability. This review systematically maps out the core principles behind developing RP-HPLC methods. We place particular focus on understanding analyte physicochemical properties, selecting the right stationary phase, balancing mobile phase thermodynamics, and tuning detectors accurately. Additionally, the manuscript offers a critical look at the mandatory validation parameters outlined in the updated International Council for Harmonisation (ICH) Q2(R2) guidelines. We discuss essential metrics—such as system suitability, linearity, accuracy, precision, and robustness—alongside the forced degradation protocols needed to build Stability-Indicating Assay Methods (SIAMs). Finally, we explore how modern analytical chemistry is changing. We highlight the growing use of Analytical Quality by Design (AQbD) to create reliable Method Operable Design Regions (MODR), as well as the push toward Green Analytical Chemistry (GAC) to shrink the environmental footprint of laboratory work.
Anju Goyal Shoaib Ahmed* (Wed,) studied this question.
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