Unit 5: Chromatographic Techniques
This unit provides an in-depth overview of chromatographic techniques used in pharmaceutical analysis, including their principles, classification, and advanced applications. It integrates recent literature insights and regulatory context, covering TLC, GC, UHPLC, SFC, and instrumentation essentials, while moving detailed HPLC content to the next unit.
Pharmaceutical analysis ensures identity, strength, purity, and composition across the drug lifecycle (discovery → manufacturing → post-market). Chromatography is highlighted for resolution, sensitivity, selectivity, and reproducibility across small molecules and biomolecules. Modern reliance includes HPLC, UHPLC, GC, and SFC, selected based on analyte properties and intended use (e.g., HPLC for stability/assay, GC for volatiles, SFC for chiral separations). These techniques are linked to method development and validation per ICH guidelines.
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