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[Impurity analysis and quality evaluation for commercial levofloxacin formulations using LC-MS/MS method]
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|June 3, 2018
Summary
A new LC-MS/MS method accurately quantifies trace impurities in levofloxacin formulations. This analysis revealed variations in drug quality across manufacturers, highlighting the importance of process control and storage for pharmaceutical product integrity.
Area of Science:
- Pharmaceutical Analysis
- Analytical Chemistry
- Drug Quality Control
Background:
- Ensuring the quality of pharmaceutical formulations is critical for patient safety and therapeutic efficacy.
- Trace impurities in drug products can arise from manufacturing processes, degradation, or storage conditions.
- Levofloxacin is a widely used antibiotic, necessitating robust methods for its quality assessment.
Purpose of the Study:
- To develop and validate a rapid, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying trace impurities in levofloxacin formulations.
- To evaluate the quality of levofloxacin formulations from various manufacturing plants by assessing impurity profiles.
- To identify and report novel impurities in levofloxacin drug products.
Main Methods:
- Development of a quantitative analytical method using LC-MS/MS.
- Analysis of levofloxacin formulations sourced from 19 different manufacturing plants.
- Identification and quantification of detected impurities, including a newly identified Levofloxacin N(4’)-methyl quaternary impurity.
Main Results:
- The developed LC-MS/MS method demonstrated high sensitivity and specificity for trace impurity detection.
- Five distinct impurities were identified across the analyzed levofloxacin samples.
- Significant variations in impurity levels were observed among products from different manufacturers, with three plants meeting a quality standard of <0.01% impurities.
- Levofloxacin N(4’)-methyl quaternary impurity was reported for the first time as a formulation impurity.
Conclusions:
- The developed LC-MS/MS method is suitable for monitoring the quality of commercial levofloxacin drug products.
- Impurities are closely linked to drug storage, formulation process control, and transportation conditions.
- Manufacturing plant and process control significantly impact the impurity profile and overall quality of levofloxacin formulations.
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