Chromatography and Analytical Techniques

Pharmaceutical Quality Control

Pharmaceutical quality control (QC) relies heavily on chromatography to ensure the purity, potency, and safety of drugs throughout the manufacturing lifecycle. High-performance liquid chromatography (HPLC) is the backbone of QC, used extensively for content uniformity, impurity profiling, dissolution testing, and stability analysis. Emerging technologies like UHPLC, two-dimensional LC, and LC-MS provide enhanced resolution and faster run times, allowing for high-throughput and more detailed analysis. Robust method development and validation are integral to meeting regulatory standards from bodies such as the FDA, EMA, and WHO. Automated sampling, data acquisition, and audit-ready software are becoming essential for compliance with Good Manufacturing Practice (GMP) regulations. Moreover, green and sustainable practices are being adopted to reduce solvent use and operational costs. Chromatographic techniques are also pivotal in detecting nitrosamines and other genotoxic impurities, which are gaining regulatory scrutiny. This session covers the role of chromatography in pharmaceutical QC, with a focus on new technologies, regulatory trends, and quality assurance strategies that support drug safety and efficacy.