Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities
| Autor: | Biljana Jančić Stojanović, Anja Tumpa, Tijana Rakić, Marko Jovanović |
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| Rok vydání: | 2015 |
| Předmět: |
Quality Control
Iohexol Clinical Biochemistry Monte Carlo method Analytical chemistry Pharmaceutical Science Robustness testing Buffers Quality by Design Analytical Chemistry chemistry.chemical_compound Isomerism Phase (matter) Drug Discovery Technology Pharmaceutical Computer Simulation HILIC Chromatography High Pressure Liquid Spectroscopy Models Statistical Chromatography Chemistry Hydrophilic interaction chromatography Design of experiments Reproducibility of Results Hydrogen-Ion Concentration Models Chemical Multivariate Analysis Design space Drug Contamination Critical quality attributes Hydrophobic and Hydrophilic Interactions Monte Carlo Method Ammonium acetate Impurities |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2015.02.046 |
| Popis: | This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. This is peer-reviewed version of the following article: Jovanović, M.; Rakić, T.; Tumpa, A.; Jančić Stojanović, B. Quality by Design Approach in the Development of Hydrophilic Interaction Liquid Chromatographic Method for the Analysis of Iohexol and Its Impurities. J. Pharm. Biomed. Anal. 2015, 110, 42–48. [https://doi.org/10.1016/j.jpba.2015.02.046] |
| Databáze: | OpenAIRE |
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