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Impurity profiling of pharmaceuticals by thin-layer chromatography.

K Ferenczi-Fodor¹, Z Végh, B Renger

¹Gedeon Richter Plc., P.O.B. 27, H-1475 Budapest, Hungary. k.fodor@richter.hu

Journal of Chromatography. A

|January 25, 2011

Summary

Thin-layer chromatography (TLC) remains a popular pharmaceutical analysis method, despite a trend towards High-Performance Liquid Chromatography (HPLC). This review highlights TLC

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Area of Science:

Pharmaceutical Analysis
Analytical Chemistry
Chromatographic Techniques

Background:

High-Performance Liquid Chromatography (HPLC) is increasingly favored in pharmacopoeias.
Thin-layer chromatography (TLC) remains a widely adopted and practical analytical technique in the pharmaceutical sector.
Established methods are crucial for maintaining quality control and research standards.

Purpose of the Study:

To showcase the versatility and applicability of Thin-layer chromatography (TLC) in pharmaceutical analysis.
To provide recent examples (last five years) of TLC's use in various pharmaceutical contexts.
To emphasize the continued relevance of TLC alongside newer chromatographic methods.

Main Methods:

Review of recent scientific literature (primarily last five years) focusing on Thin-layer chromatography (TLC) applications.
Analysis of case studies demonstrating TLC in pharmaceutical quality control and research.
Comparative overview of TLC's role versus High-Performance Liquid Chromatography (HPLC).

Main Results:

Thin-layer chromatography (TLC) is effectively utilized for in-process and intermediate control in pharmaceutical manufacturing.
TLC proves valuable for impurity testing of both active pharmaceutical ingredients (APIs) and finished drug products.
Recent research demonstrates ongoing applications of TLC in pharmaceutical research and development.

Conclusions:

Thin-layer chromatography (TLC) offers significant advantages and remains a relevant analytical tool in the pharmaceutical industry.
The method's utility spans quality control, impurity profiling, and research and development.
TLC complements other techniques like HPLC, providing a robust option for pharmaceutical analysis.