Cytotoxic drug preparation in hospital pharmacies is associated with chronic occupational exposure leading to a risk of adverse effects. The objective was to develop and validate a quantification method of the following cytotoxic drugs in environmental wipe samples: cyclophosphamide, ifosfamide, cytarabine, dacarbazine, docetaxel, paclitaxel, doxorubicin, epirubicin, etoposide, 5-fluorouracil, gemcitabine, irinotecan, methotrexate, and pemetrexed.
The quantification method was developed using liquid chromatography coupled to mass tandem spectrometry and a wiping technique using viscose swab. Linearity, accuracy, precision, limit of quantification, specificity and stability were assessed, from swab desorbed solution, to validate the analytical method, with respect to ICH guidelines. Environmental samples were collected by wiping 5 work surfaces of 225 cm2 with viscose swabs, during 3 days.
The quantification method was linear over the calibration range with a lower limit of quantification ranging from 0.5 ng.mL-1 to 5.0 ng.mL-1 depending on the cytotoxic drug. The intra-day and inter-day relatives biases were below 1.5% and 13.5%, respectively. This method was successfully applied to surface wipe sampling and environmental contaminations ranged from 0.7 to 1,840.0 ng.cm-2 for the most contaminated areas.
This 14 cytotoxic drugs quantification method was successfully applied to environmental contamination monitoring and could therefore be a useful tool for monitoring and toxicological studies.