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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).
- Source :
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Analytical and bioanalytical chemistry [Anal Bioanal Chem] 2021 Apr; Vol. 413 (9), pp. 2587-2596. Date of Electronic Publication: 2021 Feb 23. - Publication Year :
- 2021
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Abstract
- 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.
- Subjects :
- Chromatography, High Pressure Liquid methods
Cyclophosphamide analysis
Deoxycytidine analogs & derivatives
Deoxycytidine analysis
Drug Compounding
Drug Stability
Drug Storage
Fluorouracil analysis
Irinotecan analysis
Quality Control
Spectrophotometry, Ultraviolet methods
Spectrum Analysis, Raman methods
Workflow
Gemcitabine
Antineoplastic Agents analysis
Cytostatic Agents analysis
Subjects
Details
- Language :
- English
- ISSN :
- 1618-2650
- Volume :
- 413
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Analytical and bioanalytical chemistry
- Publication Type :
- Academic Journal
- Accession number :
- 33624127
- Full Text :
- https://doi.org/10.1007/s00216-021-03223-9