Technological maturity of the non-intrusive Raman spectroscopy, routinely applied to the automated pre-delivery quality control of ganciclovir compounded at the hospital: validation and comparison vs. high performance liquid chromatography reference method

Flavie Ader, Alexandre Amin, Fabrice Vidal, Philippe Bourget* Service de Pharmacie Clinique, HU Necker-Enfants Malades, 149 rue de Sèvres, 75015 Paris, France.
*philippe.bourget@nck-aphp.fr

The analytical quality control (AQC) by Raman spectroscopy (RS) of injectable medications compounded at hospital has already been the subject of several communications by our research group. The current study focuses on the technical deployment of a simple, fast and automated pre-delivery-AQC. In order to comply with existing organizations, that are already performing conventional AQC, the withdrawal of 500 L of therapeutic solution per therapeutic objet was preserved using sealed glass vials. Ganciclovir is a widely used antiviral drug which is shaped under pharmaceutical liability via dedicated manufacturing units; in the present case, it has been selected as a study model. Two minutes are required to perform the analysis by RS using a DXR SmartRaman® spectrometer (ThermoFisher Scientific) equipped with a carousel autosampler accessory design to accommodate vials. Software allows a fast and automated qualitative and quantitative analysis, using a spectral database that we have built gradually. A chemometric analysis using the Partial Least Squares regression model enhances the quantification by RS. The model is validated according to the international standards between 1.6-10 mg/mL and provided excellent results for the analytical key validation parameters, i.e., trueness, precision and uncertainty. Spearman and Kendall correlation tests (p-value < 10-15), and statistical studies performed by Bland & Altman plot, confirm a high correlation between the RS method and the reference method by HPLC. In addition to the technical merits that have already been identified for RS, e.g., a fast analysis, a complete safety for operators and their occupational environment, a non-invasive procedure, no need for consumables, and a low operating cost; these results reconfirm the technological maturity of the non-intrusive Raman spectroscopy, routinely applied to the automated pre-delivery-AQC of injectable drugs at the hospital.

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