Kamalesh Mistry,
Dhananjay Mistry,
Tusar Ranjan Patil,
Sangram Keshari Panda,
Dillip Kumar Brahma,
Manas Ranjan Nayak,
- Assistant Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Ar-ra, Durgapur, West Bengal, India
- Research Scholar, Department of Pharmacognosy, Jeypore College of Pharmacy, Bana Vihar, Randapali, Jeypore, Odisha, India
- Assistant Professor, Department of Pharmaceutical Analysis, Nityananda College of Pharmacy, Balasore, Odisha, India
- Professor, Department of Pharmacognosy, Jeypore College of Pharmacy, Bana Vihar, Randapali, Jeypore, Odisha, India
- Professor & HOD, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Arra, Durgapur, West Bengal, India
- Associate Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Arra, Durgapur, West Bengal, India
Abstract
The advancement in the pharmaceutical analysis has therefore been occasioned by the need for timely and accurate methodology as well as sensitivity in analysis to make sure that the drug quality, safety and efficacy are well established. Conventional techniques of identification, quality determination, characterization of the impurities, and estimation of chemical stability of drugs have been enhanced through spectroscopic, chromatographic, and other hyphenated techniques which boost precision and quickness in drug analysis. The techniques of HPLC, UPLC, GC-MS and NMR are important for trace-level analysis whereas technique like CE, te-rahertz spectroscopy, biosensor-based detection are used for instant, non-destructive quality analysis of pharmaceuticals. This review aims at presenting the current progress made in phar-maceutical analytical technologies and method validation and examines the pertinence of AI and ML when it comes to method devel-opment, data analysis, and regulatory compliance modeling. Taking the mantle of QbD has enhanced risk evaluation hence improvement of the robustness, precision, and reproducing of drugs. Global regulatory agencies like ICH, FDA, USP and EMA require demanding method validation for accuracy linearity, specificity, and stability in compliance to regulatory requirements but they are tough in adoption, standardiza-tion and in technology implementation such as RTRT, Blockchain technology in digital data security. Some of its future developments will potentially identify nanotechnology for drug analysis, biosensror-based detection in tailored treatment, and AI operational analytical tools to advance inclinations towards automation, analytics and standardized compliance. These chang-es will improve the Ph1 quality assurance, global compliance, as well as pave for improved an-alytical techniques in the delivery of pharmaceuticals.
Keywords: HPLC, Pharmaceutical Analysis, Biosensror-based detection, RTRT, AI operational analytical tools, GC-MS, AI and ML
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Research & Reviews: A Journal of Drug Design & Discovery
| Volume | 13 | |
| 03 | ||
| Received | 07/07/2026 | |
| Accepted | 31/10/2026 | |
| Published | 11/11/2026 | |
| Publication Time | 127 Days |