Quality control of cytostatic drug preparations : Comparison of workflow and performance of Raman/UV and high-performance liquid chromatography coupled with diode array detection (HPLC-DAD)
| Autor: | Jochen Tuerk, Lars M H Reinders, Thorsten Teutenberg, Martin Jaeger, Claudia vom Eyser, Martin D Klassen, Torsten C. Schmidt |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Active ingredient
Chromatography Materials science 010401 analytical chemistry Chemie 02 engineering and technology 021001 nanoscience & nanotechnology 01 natural sciences Biochemistry High-performance liquid chromatography 0104 chemical sciences Analytical Chemistry Irinotecan symbols.namesake Analytical quality control symbols medicine Measurement uncertainty Gravimetric analysis 0210 nano-technology Raman spectroscopy Counterfeit Drugs medicine.drug |
| Popis: | The drugs used for treatment during chemotherapy are manufactured individually for each patient in specialised pharmacies. Thorough quality control to confirm the identity of the delivered active pharmaceutical ingredient and the final concentration of the prepared application solution is not standardized yet except for optical or gravimetric testing. However, solution stability problems, counterfeit drugs, and erroneous or deliberate underdosage may occur and negatively influence the quality of the product and could cause severe health risks for the patient. To take a step towards analytical quality control, an on-site analytical instrument using Raman and UV absorption spectroscopy was employed and the results were compared to high-performance liquid chromatography coupled to diode array detection. Within the scope of the technology evaluation, the uncertainty of measurement was determined for the analysis of the five frequently used cytostatic drugs 5-fluorouracil, cyclophosphamide, gemcitabine, irinotecan and paclitaxel. The Raman/UV technique (2.0–3.2% uncertainty of measurement; level of confidence: 95%) achieves a combined uncertainty of measurement comparable to HPLC-DAD (1.7–3.2% uncertainty of measurement; level of confidence: 95%) for the substances 5-fluorouracil, cyclophosphamide and gemcitabine. However, the uncertainty of measurement for the substances irinotecan and paclitaxel is three times higher when the Raman/UV technique is used. This is due to the fact that the Raman/UV technique analyses the undiluted sample; therefore, the sample has a higher viscosity and tendency to foam. Out of 136 patient-specific preparations analysed within this study, 96% had a deviation of less than 10% from the target content. |
| Databáze: | OpenAIRE |
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