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Abstract
Pharmaceutical quality control (QC) is the cornerstone of ensuring that medicines are safe, effective, and consistent. Traditional methods such as titration, UV–visible spectroscopy, thin layer chromatography, and microbiological assays provided the foundation for early drug testing but often lacked sensitivity, reproducibility, and scope for modern complex formulations. The growing sophistication of therapeutics—including biologics, vaccines, and nanomedicines—has driven the adoption of advanced analytical techniques that offer greater precision, specificity, and robustness.
This review explores the evolution of QC from conventional approaches to advanced methodologies such as chromatography, spectroscopy, mass spectrometry, and hyphenated techniques, alongside the integration of Process Analytical Technology (PAT). It highlights the critical role of method validation in ensuring reliability and global harmonization, while examining applications across small molecules, biologics, nanomedicines, vaccines, and personalized therapies. The advantages of these techniques—ranging from real time monitoring to predictive modeling—are balanced against challenges of cost, expertise, regulatory adaptation, and global accessibility.
Looking ahead, the future of QC lies in digitalization, automation, and artificial intelligence, transforming it from a confirmatory process into a predictive discipline. By uniting scientific rigor with ethical responsibility, advanced analytical techniques redefine pharmaceutical quality as both a technical safeguard and a moral commitment to patient safety.
Keywords:
Keywords- Pharmaceutical Quality Control (QC), Advanced Analytical Techniques, Chromatography , Spectroscopy, Mass Spectrometry, Hyphenated Techniques, Process Analytical Technology (PAT) Method Validation, Biologics and Vaccines
Cite Article:
"Advanced Analytical Techniques in Pharmaceutical Quality Control: Applications, Method Validation, and Future Perspectives", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2456-3315, Vol.11, Issue 4, page no.a620-a628, April-2026, Available :http://www.ijrti.org/papers/IJRTI2604088.pdf
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator