An ion-pairing, reversed-phase liquid chromatography method to assess the cross-contamination of cancer chemotherapy infusions prepared in a dual-operator aseptic isolator

摘要

Cytotoxics are usually prepared in a centralized pharmacy unit in a controlled hospital environment. Despite the rigorous operating procedures used for such preparations, contamination is theoretically possible - for example due to vial switches. Therefore products ought to be checked in order to determine whether quality control measures are adequate. Numerous strategies have been applied locally to ensure the safety of both patients and operators but the efficacy of these methodologies has not previously been examined. The aim of this study was to develop an analytical method sensitive enough to detect traces of anti-cancer drugs, in order to evaluate cross-contamination between infusions prepared in a dual-operator isolator in the dedicated pharmacy unit. We developed a high performance liquid chromatography (HPLC) method with ultraviolet (UV) detection to identify and quantify the following seven drugs: 5-Fluorouracil, Cytarabine, Gemcitabine, Irinotecan, Doxorubicin, Epirubicin, and Daunorubicin. We assessed the levels of cross-contamination in 20 random preparations. We achieved separation of the seven drugs in less than 28 min, with a lower limit of quantification capable of detecting cross-contamination. An assessment of 20 preparations revealed no cross-contamination. We developed a reproducible and sensitive HPLC method which could be a potentially useful tool for use in practice. We checked the level of cross-contamination in anti-cancer drug infusions and confirmed that the process in current use was safe. This study is the first to assess cross-contamination in anti-cancer preparations. This work is the first step in an extensive programme of quality control, whose aim is to ensure the safety of both patients and operators. Copyright (C) 2015 John Wiley & Sons, Ltd.