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A critical quality parameter in quantitative fused-core chromatography: The injection volume
Jente Boonen1, Matthias D'hondt1, Lieselotte Veryser1
1Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Journal of Pharmaceutical Analysis
|February 7, 2018
Summary
Injection volume significantly impacts fast fused-core chromatography performance. Optimizing this critical quality attribute is essential for accurate method validation, especially when considering different sample solvents.
Area of Science:
- Analytical Chemistry
- Chromatography
Background:
- Fast fused-core chromatography is a rapidly developing technique.
- Critical quality attributes require thorough evaluation for method development and validation.
Purpose of the Study:
- To evaluate injection volume as a critical quality attribute in fast fused-core chromatography.
- To investigate the influence of injection volume on chromatographic performance using Spilanthol as a model compound.
Main Methods:
- Analysis of Spilanthol using a fused-core chromatography system.
- Evaluation of injection volumes ranging from 2 μL to 100 μL.
- Assessment of five chromatographic responses: retention time, area, height, theoretical plates, and symmetry factor.
- Comparison of sample solvents: PBS and MeOH/H2O (70/30, v/v).
Main Results:
- Injection volume significantly affected both qualitative and quantitative performance, confounded by sample solvent.
- With PBS, increasing injection volume (2-100 μL) favorably decreased symmetry factor by 20% and increased theoretical plates, area, and height by up to 30%.
- With MeOH/H2O, increasing injection volume decreased theoretical plates by over 60% and increased symmetry factor and decreased height by 30%.
Conclusions:
- Injection volume is a critical and frequently overlooked parameter in fused-core chromatography method development and validation.
- The effect of injection volume is highly dependent on the sample solvent used.
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