Cyclophosphamide identification in wipe test by GC-MS and solid phase extraction

Abstract

In this study cyclophosphamide was quantified after adapting a prior analytical method using gas chromatography-mass spectrometry after solid phase purification and derivatization with trifluoroacetic anhydride. The analyte was measured by analysis in wipe test from infusion bags, which may be contaminated by contact with the gloves used during preparation of the drugs. Surface of bag contaminated may be an important source of contamination for workers in the others chemoterapy handling areas, such as administration rooms. This drug, in fact, is one of the most frequently used alkylating antineoplastic agents for different types of tumors and it is furthermore classified as a human carcinogen by IARC. Ifosfamide was used as internal standard and the quantification was carried out by reference to calibration curves within a range from 1 to 100 ng/mL. The limit of detection was 0.4 ng/mL. The values of the variation coefficient varied from 0.5 to 10% (intra-assay) and from 0 to 19% (interassay). Frozen reference wipe samples containing cyclophosphamide were analysed over one month and no significant loss was observed. The range obtained for bias assay was 83-116% and the recovery was 98.9%. Cyclophosphamide was measured in 36 of 42 infusion bags collected from different hospitals with values ranging from 90 to 41874 ng (median= 607.5 ng). The results, well related to those reported in the literature, suggest that this method can be used to identify cyclophosphamide from wipe samples and can be considered useful in exposure assessment to this drug.