Validation and uncertainty estimation for trace amounts determination of 25 drugs used in hospital chemotherapy compounding units

Autor: Sandrine Fleury-Souverain, Pascal Bonnabry, Nicolas Guichard, Serge Rudaz
Rok vydání: 2019
Předmět:
Zdroj: Journal of Pharmaceutical and Biomedical Analysis, Vol. 172 (2019) pp. 139-148
ISSN: 0731-7085
DOI: 10.1016/j.jpba.2019.04.042
Popis: The validation and uncertainty assessment of the analytical method developed for the simultaneous determination of 25 anticancer drugs commonly handled in hospital pharmacy was reported. Selected compounds were 5-fluorouracil, cytarabine, fludarabine phosphate, ganciclovir, gemcitabine, dacarbazine, methotrexate, pemetrexed, busulfan, raltitrexed, etoposide phosphate, topotecan, ifosfamide, cyclophosphamide, irinotecan, doxorubicin, epirubicin, daunorubicin, idarubicin, vincristine, vinblastine, vinorelbine, docetaxel and paclitaxel. Accuracy and uncertainty profiles were obtained for all compounds. Quantitative performances were satisfactory in term of specificity, sensitivity, precision and accuracy. Repeatability (1.9–25.4%) and intermediate precision (2.7–29%) were determined for all target compounds. Lower limits of quantification between 1 and 25 ng/mL were obtained. Uncertainty associated to measurement of routine samples was evaluated. The multi-targeted method was specific and reliable and was successfully applied to wipe samples from hospital pharmacy chemotherapy compounding unit and to the determination of outside contamination of vials from pharmaceutical manufacturers.
Databáze: OpenAIRE