Applications of hyphenated LC-MS techniques in pharmaceutical analysis

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• Mass spectrometry (MS) coupled with chromatography is essential for pharmaceutical analysis, including quality control and impurity identification.
• Hyphenated techniques enhance chromatographic separations, supporting pharmaceutical development and ensuring drug safety.

Purpose of the Study:

• To highlight the power of mass spectrometry (MS) coupled with chromatography in pharmaceutical analysis.
• To demonstrate the application of MS in impurity characterization, method development, and validation.

Main Methods:

• Utilizing hyphenated chromatographic and mass spectrometry techniques (e.g., LC-MS, LC-MS-MS).
• Employing high-resolution MS and MS/MS fragmentation for structural elucidation.
• Applying mass-specific detection for chiral amino acid analysis.

Main Results:

• MS detection effectively supports chromatographic method development and validation, aiding in coelution and peak purity investigations.
• LC-MS systematically monitors impurity profiles during pharmaceutical development and scale-up.
• Structural elucidation of degradation products and impurities is achieved using LC-MS-MS and high-resolution MS.

Conclusions:

• Mass spectrometry is a critical technique for comprehensive pharmaceutical analysis, impurity monitoring, and ensuring drug safety.
• The described MS applications facilitate robust analytical development and quality control in the pharmaceutical industry.