Analytical Protocol for Monitoring Workplace Surface Contamination with Capecitabine

CURRENT PHARMACEUTICAL ANALYSIS(2022)

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摘要
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 an 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 pro drug. Results: The applied HPLC-UV method was assessed as accurate and precise, with an established limit of quantification of 0.05 mu g/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.
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关键词
Capecitabine, HPLC-UV, occupational exposure, wipe sample, drugs, cytotoxic complications
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