Kamalesh Mistry,
Dhananjay Mistry,
Tusar Ranjan Pati,
Sangram Keshari Panda,
Dillip Kumar Brahma,
Manas Ranjan Nayak,
- Assistant Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Arra, 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
High Performance Thin Layer Chromatography (HPTLC) is a versatile analytical technique which has been effectively used for pharmaceutical quality control and cost effectively, rapidly, and high throughput analyzed tablet formulations. HPTLC is different from traditional chromatographic methods as multi sample analysis is possible in one run with low consumption of solvent, which are principles of green analytical chemistry. But existing HPTLC is limited in sensitivity, resolution and reproducibility and these are limiting factors in achieving accuracy and regulatory compliance that HPTLC methods such as other related technologies do not suffer. HPTLC for pharmaceutical tablet formulations has been reviewed with innovations in the detection systems, method optimization strategies and regulatory perspectives. This shows the advances made in the separation techniques, chemometric assisted method development, hyphenated HPTLC techniques (HPTLC-MS, HPTLC-FTIR and HPTLC-NMR), and Quality by Design (QbD) approaches. The point is to develop HPTLC as a feasible alternative to HPLC and UPLC on the grounds of precision, sensitivity, and validation method. It describes HPTLC theoretical principles, by reviewing separation mechanisms, critical chromatographic parameters and instrumental improvements. It discusses the latest ICH Q2 (R1) validation requirements regarding accuracy precision linearity robustness and detection limit, and goes on discussing the use of the system in impurity profiling stability testing and bioanalytical applications. In addition, the integration of AI driven data processing, cloud based analytics, blockchain for regulatory compliance is also explored. HPTLC has advanced to the point that separation efficiency, detection sensitivity and reproducibility are much improved. This has improved reliability of the method by incorporating automated sample application to pipette tips, densitometric detection, and chemometric algorithms. HPTLC’s role in green analytical chemistry, along with its adaptability to pharmaceutical formulations, positions it as a key technique for future pharmaceutical quality control. With such success in quality monitoring, the future of HPTLC looks to be in real time, miniaturised platforms, AI assisted data interpretation and improved bioanalytical applications. In addition, blockchain will become more industrial and clinical relevant in terms of data security and regulatory transparency.
Keywords: High-Performance Thin-Layer Chromatography, pharmaceutical analysis, hyphenated techniques, green analytical chemistry, AI-driven data processing, quality control, regulatory compliance.
[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production ]
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| Volume | 13 | |
| Issue | 03 | |
| Received | 07/07/2026 | |
| Accepted | 24/09/2026 | |
| Published | 28/09/2026 | |
| Publication Time | 83 Days |