The Impact of Advanced Analytical Techniques in Drug Quality Assurance: Ensuring Safety and Efficacy in Pharmaceuticals

Abstract

In the pharmaceutical industry, advanced analytical techniques have revolutionized pharmaceutical quality assurance and have developed robust solutions to the assurance of the safety, efficacy and quality of drug products throughout their lifecycle. This review highlights the latest analytical methodologies including mass spectrometry (MS), spectroscopy, chromatography and chemometric procedures for improving drug quality and regulatory compliance, and their roles. Impurity profiling, real time monitoring, and formulation development have relied on techniques such as Raman spectroscopy, near infrared (NIR) spectroscopy, LC-MS and ultra high performance liquid chromatography (UHPLC). These methods provide for precise analysis of active pharmaceutical ingredient (API) as well as excipients and impurities, consistent with the rigorous global regulatory norms. Also, the data analytics, portable spectroscopic devices, and hybrid systems had simplified the workflow reducing the analysis time and improvising efficiency. Nevertheless, the challenges of high costs, regulatory compliance and complexities of modern formulations have restricted the progress, but ongoing innovations in AI-driven analytics and instrument sensitivity allow the challenges to be overcome. It was shown that advanced analytical techniques for pharmaceutical quality assurance actually have led to huge transformative impact on public health and continual improvement in delivery of healthcare.