High-performance liquid chromatography (HPLC) stands as a fundamental technique in pharmaceuticals, enabling precise compound separation based on physicochemical properties. Its pivotal role spans from initial drug discovery phases to the stringent requirements of commercial manufacturing, ensuring product quality and compliance. Method development timelines vary, with complexity and sensitivity affecting the duration. The goal is to create robust and reproducible methods that ensure compliance. Understanding a molecule’s behavior in different media and leveraging prior knowledge can expedite method development. Collaboration between R&D scientists and quality control (QC) personnel and between innovator companies and their contract development and manufacturing organization (CDMO) partners is essential for successful method development, as it ensures suitability for intended use and resolves potential issues. This article covers the many applications for HPLC in drug development and manufacturing, and details how vital a partnership is for success.
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