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Updated: May 9, 2026
Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
[Impurity profiling of macrolide antibiotics by liquid chromatography-mass spectrometry]
1National Institutes for Food and Drug Control, Beijing 100050, China.
Abstract:
Macrolide antibiotics are broad-spectrum, with activity against a range of Gram-positive, Gram-negative organisms and some anaerobes. The components of macrolide antibiotics are generally complicated. Therefore, it is very important to establish impurity profiles of these antibiotics to ensure their safety and process control. Compared with classical methods, the liquid chromatography-mass spectrometry method is particularly advantageous to characterize minor components at trace levels in terms of sensitivity, efficiency and selectivity, thus more and more widely used in establishments of impurity profiles. In this study, the general approaches to characterize minor components in complex pharmaceutical matrix, fragmentation pathways of 14- and 16-membered macrolide antibiotics and the establishment of the impurity profile of acetylspiramycin were given to provide valuable enlightenments to establish the impurity profiles of pharmaceutical products.
Insights
Establishing impurity profiles for macrolide antibiotics is crucial for safety. Liquid chromatography-mass spectrometry offers a sensitive method for characterizing trace components in complex pharmaceutical products.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Organic Chemistry
Background:
- Macrolide antibiotics exhibit broad-spectrum activity but possess complex compositions.
- Ensuring the safety and process control of macrolide antibiotics necessitates detailed impurity profiling.
- Classical methods often lack the sensitivity required for trace component analysis in pharmaceuticals.
Purpose of the Study:
- To outline general strategies for characterizing minor components within complex pharmaceutical matrices.
- To elucidate fragmentation pathways specific to 14- and 16-membered macrolide antibiotics.
- To establish a comprehensive impurity profile for acetylspiramycin.
Main Methods:
- Utilizing liquid chromatography-mass spectrometry (LC-MS) for high sensitivity, efficiency, and selectivity.
- Applying LC-MS to analyze complex pharmaceutical samples and identify trace impurities.
- Investigating fragmentation patterns of macrolide antibiotics using mass spectrometry.
Main Results:
- Demonstrated the effectiveness of LC-MS in characterizing minor components at trace levels.
- Provided insights into the fragmentation pathways of 14- and 16-membered macrolide antibiotics.
- Successfully established the impurity profile of acetylspiramycin.
Conclusions:
- LC-MS is a powerful tool for impurity profiling of macrolide antibiotics.
- Understanding fragmentation pathways aids in the identification of macrolide impurities.
- The presented approaches offer valuable guidance for impurity profiling in pharmaceutical development.
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