title: Routine application of Raman spectroscopy in the quality control of hospital compounded ganciclovir.
abstract: This study compares the performance of a reference method of HPLC to Raman spectroscopy (RS) for the analytical quality control (AQC) of therapeutic objects. We assessed a model consisting of a widely used antiviral drug, i.e., ganciclovir, which was compounded in a medical device and then transferred in a vacuum glass vial prior to analyses. As the aim of the alternative RS method is to replace the destructive, time-consuming HPLC method, requiring sample preparation, it needs to be demonstrated that RS performs at least as good as the HPLC method. Therefore, the two methods were validated by calculating the accuracy profile and provided excellent results for the analytical validation key criteria, i.e., trueness, precision and accuracy, ranging from 0.8 to 10mg/mL. The Spearman and Kendall correlation tests (p-value<1.10-15) and the statistical studies performed on the graphs confirm a strong correlation in the results between RS and the standard HPLC under the experimental conditions. These results confirmed the potential of this option for future applications, owing to its analytical and practical quality and its contributions to the safety of the medication circuit. This method also greatly contributes to the protection of caregivers and their working environment.
authors.affiliation: Clinical Pharmacy Department, HU Necker-Enfants Malades, 149 rue de Sèvres, 75743 Paris cedex 15, France. Electronic address: alexandre.amin@nck.aphp.fr.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Amin
authors.affiliation: Clinical Pharmacy Department, HU Necker-Enfants Malades, 149 rue de Sèvres, 75743 Paris cedex 15, France. Electronic address: philippe.bourget@nck.aphp.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bourget
authors.affiliation: Clinical Pharmacy Department, HU Necker-Enfants Malades, 149 rue de Sèvres, 75743 Paris cedex 15, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Vidal
authors.affiliation: Clinical Pharmacy Department, HU Necker-Enfants Malades, 149 rue de Sèvres, 75743 Paris cedex 15, France.
authors.forename: Flavie
authors.initials: F
authors.lastname: Ader
mesh_terms: D000998:Antiviral Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D015774:Ganciclovir / Q000737:chemistry*; D011786:Quality Control; D013059:Spectrum Analysis, Raman
chemical_list: D000998:Antiviral Agents; D015774:Ganciclovir
keywords: Analytical quality control; Ganciclovir; Ganciclovir (PubChem CID: 3454); HPLC; Hospital environment; Raman spectroscopy; Safety