Sottani Cristina, Turci Roberta, Schierl Rudolf, Gaggeri Raffaella, Barbieri Anna, Violante Francesco Saverio, Minoia Claudio
Laboratory for Environmental and Toxicological Testing, S. Maugeri Foundation, IRCCS, via Maugeri 10, Pavia, Italy.
Rapid Commun Mass Spectrom. 2007;21(7):1289-96. doi: 10.1002/rcm.2960.
Measurable levels of anticancer agents are still detected on work surfaces in health-care settings. However, application of recent guidelines for the protection of workers' safety and health has resulted in lowered contamination levels. To assess occupational exposure to antineoplastic agents, very sensitive and specific procedures for environmental sampling and analysis are therefore needed. In the present study an assay for simultaneous determination of gemcitabine, taxol, cyclophosphamide, and ifosfamide in wipe samples, using two internal standards (trofosfamide and cephalomannine), was developed and validated by high-performance liquid chromatography/tandem mass spectrometry (HPLC/MS/MS). Solid-phase extraction (SPE) was used for sample concentration and cleanup. The assay was found to be linear up to 1000 ng/wipe, with limits of quantitation of 25.0 ng/wipe for gemcitabine and taxol, and 12.5 ng/wipe for cyclophosphamide and ifosfamide. In order to investigate the effectiveness of the surface sampling, removal efficiency tests were repeated on different types of surfaces. Recovery rates of between 62 and 81% were obtained at two contamination levels (50.0 and 250 ng/100 cm2). Precision and trueness were determined on three different days. The within-day precision was found to be always less than 12.1% for all the analytes. The overall precision, expressed as relative standard deviation (RSD), was always less than 9.4%. Recoveries varying from 75.0 (gemcitabine) to 95.0% (taxol) were obtained at three levels. In order to obtain a quantitative indication of the quality of the result, the overall uncertainty of measurement (UOM) was evaluated according to the EURACHEM/CITAC guide. The relative combined uncertainty was found to be always less than 9.5%. The relative expanded uncertainty was also calculated, at three contamination levels.
在医疗保健机构的工作表面仍能检测到可测量水平的抗癌药物。然而，应用近期的工人安全与健康保护指南已使污染水平降低。因此，为评估职业接触抗肿瘤药物的情况，需要非常灵敏且特异的环境采样和分析程序。在本研究中，开发了一种使用两种内标（曲磷胺和头状曼宁）同时测定擦拭样本中吉西他滨、紫杉醇、环磷酰胺和异环磷酰胺的方法，并通过高效液相色谱/串联质谱法（HPLC/MS/MS）进行了验证。采用固相萃取（SPE）进行样品浓缩和净化。该方法在高达1000 ng/擦拭的范围内呈线性，吉西他滨和紫杉醇的定量限为25.0 ng/擦拭，环磷酰胺和异环磷酰胺的定量限为12.5 ng/擦拭。为研究表面采样的有效性，在不同类型的表面上重复进行了去除效率测试。在两种污染水平（50.0和250 ng/100 cm²）下获得的回收率在62%至81%之间。在三个不同的日子测定了精密度和准确性。发现所有分析物的日内精密度始终小于12.1%。以相对标准偏差（RSD）表示的总精密度始终小于9.4%。在三个水平下获得的回收率从75.0%（吉西他滨）到95.0%（紫杉醇）不等。为获得结果质量的定量指示，根据EURACHEM/CITAC指南评估了测量的总不确定度（UOM）。发现相对合成不确定度始终小于9.5%。还计算了三个污染水平下的相对扩展不确定度。
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