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Analytical Protocol for Monitoring Workplace Surface Contamination with Capecitabine
Current Pharmaceutical Analysis ( IF 0.7 ) Pub Date : 2021-12-31 , DOI: 10.2174/1573412917666201217164305
Stanila Stoeva 1 , Petko Marinov 1
Affiliation  

Background: The risk of toxicity for the healthy individuals who are chronically exposed to cytostatic drugs was established in 1970s. Since then, many institutions have recommended monitoring occupational exposure to antineoplastic agents. Nevertheless, there is still a lack of analytical procedures for this inspection. The prodrug Capecitabine is an example of a cytostatic drug that has never been analyzed for the purpose of occupational exposure inspection. Thus, the objective of the present study was to develop a suitable protocol for its evaluation on workplace surfaces.

Methods: The determination of the surface residue of Capecitabine has been carried out in a laboratory setting through аn HPLC-UV method, preceded by an appropriate sample preparation procedure,. It was used for the pre-and post-cleaning analysis of wipe samples from several working sites, which are assessed as the most likely ones for the occurrence of dermal contact with the prodrug.

Results: The applied HPLC-UV method was assessed as accurate and precise, with an established limit of quantification of 0.05 μg/mL. The analytical procedure provided a recovery of Capecitabine of more than 90%. During the analytical protocol approbation, one surface sample containing Capecitabine was detected. To determine the efficiency of routine hygiene measures, wipe samples from all tested surfaces were analyzed after a cleaning procedure. However, the cytostatic presence was not determined on any area, including the area that gave a positive result.

Conclusion: The analytical protocol developed here successfully permits, for the first time, to study the surface contamination with the cytotoxic agent, Capecitabine. Due to this, it can be concluded that the proposed method could be useful for institutions where a potential risk of contamination to the prodrug exists.



中文翻译:

用卡培他滨监测工作场所表面污染的分析方案

背景:长期接触细胞抑制药物的健康个体的毒性风险是在 1970 年代确定的。从那时起,许多机构建议监测抗肿瘤药物的职业暴露。尽管如此,该检查仍缺乏分析程序。前药卡培他滨是细胞生长抑制药物的一个例子,从未用于职业暴露检查的目的。因此,本研究的目的是开发一个合适的协议来评估工作场所表面。

方法:卡培他滨表面残留物的测定是在实验室环境中通过 HPLC-UV 方法进行的,然后是适当的样品制备程序。它用于对来自多个工作场所的擦拭样品进行清洁前和清洁后分析,这些样品被评估为最有可能与前药发生皮肤接触的样品。

结果:所应用的 HPLC-UV 方法被评估为准确和精确,确定的定量限为 0.05 μg/mL。分析程序提供了超过 90% 的卡培他滨回收率。在分析方案批准期间,检测到一个含有卡培他滨的表面样品。为了确定常规卫生措施的效率,在清洁程序后分析了所有测试表面的擦拭样品。然而,没有在任何区域确定细胞抑制剂的存在,包括给出阳性结果的区域。

结论:这里开发的分析协议第一次成功地允许研究细胞毒性剂卡培他滨的表面污染。因此,可以得出结论,所提出的方法对于存在前药潜在污染风险的机构可能有用。

更新日期:2021-11-23
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