Background On-line control of chemotherapy production is used for 27 molecules at European Georges Pompidou Hospital which corresponds to 70% of the production. Flow injection analysis (FIA) constitutes the optimal method under ultra-violet spectral data identification. If the spectra are similar, the retention time after chromatographic separation has to be used for identification. The FIA spectral differences of taxanes (docetaxel, paclitaxel, cabazitaxel) are too poor for identification.
Purpose The aim of this study was to develop an ultra-fast high performance liquid chromatographic technique for on-line analytical checking of taxane preparations.
Materials and Methods Docetaxel (Sanofi-Aventis), paclitaxel (Hospira) and cabazitaxel (Sanofi-Aventis) were prepared in sodium chloride 0.9% solution. Chromatography was performed using Prostar Varian chromatographic equipment with a Photodiode Array Detector. All the separation was done with a Polaris C18 pre-column (3 µm, 10 mm × 2 mm). The mobile phase was ultra-pure water/acetonitrile (60–40 v/v). Taxanes were eluted at the flow rate of 1.2 mL.min−1.
Results Paclitaxel spectra obtained after chromatographic separation differ significantly from those of cabazitaxel and docetaxel, which are very similar. So the latter have to be identified by their retention time: 0.7 min for cabazitaxel and 0.4 min for docetaxel with a resolution of 1.7. Paclitaxel retention time was 0.39 with a resolution of 0.11 with docetaxel. The linear range corresponds to the therapeutic concentrations. The 3 methods were linear (R > 0.995) with intra-day precision from 0.27% to 2.68% and inter-day precision from 0.95% to 3.7%.
Conclusions Ultra-fast chromatographic separation methods have been successfully developed for the identification and quantification of 3 different taxane molecules. Less than 1 min is needed when spectral and retention data are combined as the main parameters.
No conflict of interest.
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