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Development of Impurity Profiling Methods Using Modern Analytical Techniques.

Bondigalla Ramachandra¹

¹a Department of Chemistry , Government Degree College , Rajampeta , Andhra Pradesh , India.

Critical Reviews in Analytical Chemistry

|April 13, 2016

Summary

This review highlights novel analytical methods for determining process- and product-related impurities in pharmaceuticals. It emphasizes techniques like UPLC, LC-MS, and NMR for ensuring drug quality, safety, and efficacy.

Keywords:

Degradation studies genotoxic impurities impurity profiling modern analytical techniques stability indicating assay methods

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Area of Science:

Pharmaceutical Analysis
Analytical Chemistry

Background:

Impurities in drug substances and products can impact quality, efficacy, and safety.
Understanding impurity sources and their adverse effects is crucial for pharmaceutical development.

Purpose of the Study:

To review novel analytical methods for impurity determination.
To emphasize the significance of impurity profiling and quality control.

Main Methods:

Ultra-performance liquid chromatography (UPLC)
Liquid chromatography-mass spectrometry (LC-MS)
High-resolution mass spectrometry (HRMS)
Gas chromatography-mass spectrometry (GC-MS)
High-performance thin layer chromatography (HPTLC)
Nuclear magnetic resonance (NMR) spectroscopy

Main Results:

Modern analytical techniques offer sensitive and specific impurity detection.
Forced degradation studies and stability-indicating methods are essential for characterizing degradation products.

Conclusions:

Development of advanced analytical methods is vital for robust impurity profiling.
Comprehensive impurity characterization ensures drug safety, efficacy, and regulatory compliance.