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Optimization of HPLC method for stability testing of bacitracin
1Department for Stability Testing, Krka Pharmaceuticals, Novo mesto, Slovenia. viljem.pavli@krka.si
Journal of Pharmaceutical and Biomedical Analysis
|March 15, 2001
Summary
A new high-performance liquid chromatography (HPLC) method accurately analyzes bacitracin in complex samples. This validated assay ensures precise quantification of bacitracin components and impurities.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Bacitracin is a crucial antibiotic used in animal feed.
- Accurate quantification of bacitracin and its components is essential for quality control.
Purpose of the Study:
- To develop and validate a stability-indicating HPLC assay for bacitracin.
- To optimize the HPLC method for complex matrices like zinc bacitracin feed grade.
Main Methods:
- Gradient elution, reversed-phase HPLC with UV diode array detection.
- Systematic optimization of mobile phase pH and column selection.
- Analysis of complex samples including zinc bacitracin feed grade.
Main Results:
- Developed a highly selective and effective HPLC assay for bacitracin.
- Investigated the chromatographic separation of active (A, B(1), B(2)) and inactive (F) components.
- Identified subunits within bacitracin peaks B(1) and F, likely isomers.
Conclusions:
- The validated HPLC method enables simultaneous determination of bacitracin polypeptides, impurities, and degradation products.
- The assay is suitable for quality control of bacitracin in feed additives.
- The method provides a robust tool for analyzing complex bacitracin formulations.