Abstract
Portable Near Infrared spectroscopy (NIRs) coupled to chemometrics was investigated for the first time as a novel entirely on-site approach for occupational exposure monitoring in pharmaceutical field. Due to a significant increase in the number of patients receiving chemotherapy, the development of reliable, fast, and on-site analytical methods to assess the occupational exposure of workers in the manufacture of pharmaceutical products, has become more and more required. In this work, a fast, accurate, and sensitive detection of hydroxyurea, a cytotoxic antineoplastic agent commonly used in chemotherapy, was developed. Occupational exposure to antineoplastic agents was evaluated by collecting hydroxyurea on a membrane filter during routine drug manufacturing process. Spectra were acquired in the NIR region in reflectance mode by the means of a miniaturized NIR spectrometer coupled with chemometrics. This MicroNIR instrument is a very ultra-compact portable device with a particular geometry and optical resolution designed in such a manner that the reduction in size does not compromise the performances of the spectrometer. The developed method could detect up to 50 ng of hydroxyurea directly measured on the sampling filter membrane, irrespective of complexity and variability of the matrix; thus extending the applicability of miniaturized NIR instruments in pharmaceutical and biomedical analysis.
Highlights
Hydroxyurea (HU) or hydroxycarbamide, is a non-alkylating hydroxylated urea analog mainly recognized as antineoplastic and antiviral agent (Spivak and Hasselbalch, 2011)
A number of variables were considered in order to ensure a correct and representative sampling procedure: (a) membrane type and sampling side; (b) sampling procedure to reproduce HU exposure in terms of volume to be added on a filter; (c) spectra acquisition
All the acquired MicroNIR data corresponding to different experimental conditions were pre-treated and processed by a simple exploratory tool such as Principal Component Analysis (PCA)
Summary
Hydroxyurea (HU) or hydroxycarbamide, is a non-alkylating hydroxylated urea analog mainly recognized as antineoplastic and antiviral agent (Spivak and Hasselbalch, 2011). The cytotoxic and genotoxic potential efficacy of hydroxyurea makes this molecule one of the most performing agent commonly used in chemotherapy (Spivak and Hasselbalch, 2011; Karsy et al, 2016; Liew et al, 2016). Workers involved in the manufacture of drugs, may be exposed to HU during manufacturing, transport, and distribution. As the number of patients receiving chemotherapy has considerably increased, there is a growing concern about the development of MicroNIR/Chemometrics Detection of Hydroxyurea reliable, fast and accurate methods to assess the occupational exposure of workers during drug manufacturing process
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