Routine application of Raman spectroscopy in the quality control of hospital compounded ganciclovir
| Autor: | Alexandre Amin, Flavie Ader, Fabrice Vidal, Philippe Bourget |
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| Rok vydání: | 2014 |
| Předmět: |
Quality Control
Ganciclovir Accuracy and precision business.industry Kendall tau rank correlation coefficient media_common.quotation_subject Analytical chemistry Pharmaceutical Science Spectrum Analysis Raman Antiviral Agents Reliability engineering Analytical quality control symbols.namesake medicine symbols Sample preparation Quality (business) Raman spectroscopy business Chromatography High Pressure Liquid Working environment medicine.drug media_common |
| Zdroj: | International Journal of Pharmaceutics. 474:193-201 |
| ISSN: | 0378-5173 |
| DOI: | 10.1016/j.ijpharm.2014.08.028 |
| Popis: | This study compares the performance of a reference method of HPLC to Raman spectroscopy (RS) for the analytical quality control (AQC) of therapeutic objects. We assessed a model consisting of a widely used antiviral drug, i.e., ganciclovir, which was compounded in a medical device and then transferred in a vacuum glass vial prior to analyses. As the aim of the alternative RS method is to replace the destructive, time-consuming HPLC method, requiring sample preparation, it needs to be demonstrated that RS performs at least as good as the HPLC method. Therefore, the two methods were validated by calculating the accuracy profile and provided excellent results for the analytical validation key criteria, i.e., trueness, precision and accuracy, ranging from 0.8 to 10mg/mL. The Spearman and Kendall correlation tests (p-value |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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