[The Raman Spectroscopy (RS): A new tool for the analytical quality control of injectable in health settings. Comparison of RS technique versus HPLC and UV/Vis-FTIR, applied to anthracyclines as anticancer drugs].
The study compares the performances of three analytical methods devoted to Analytical Quality Control (AQC) of therapeutic solutions formed into care environment, we are talking about Therapeutics Objects(TN) (TOs(TN)). We explored the pharmacological model of two widely used anthracyclines i.e. adriamycin and epirubicin. We compared the performance of the HPLC versus two vibrational spectroscopic techniques: a tandem UV/Vis-FTIR on one hand and Raman Spectroscopy (RS) on the other. The three methods give good results for the key criteria of repeatability, of reproducibility and, of accuracy. A Spearman and a Kendall correlation test confirms the noninferiority of the vibrational techniques as an alternative to the reference method (HPLC). The selection of bands for characterization and quantification by RS is the results of a gradual process adjustment, at the intercept of matrix effects. From the perspective of a AQC associated to release of TOs, RS displays various advantages: (a) to decide quickly (~2min), simultaneously and without intrusion or withdrawal on both the nature of a packaging than on a solvant and this, regardless of the compound of interest; it is the founder asset of the method, (b) to explore qualitatively and quantitatively any kinds of TOs, (c) operator safety is guaranteed during production and in the laboratory, (d) the suppression of analytical releases or waste contribute to protects the environment, (e) the suppression.of consumables, (f) a negligible costs of maintenance, (g) a small budget of technicians training. These results already show that the SR technology is potentially a strong contributor to the safety of the medication cycle and fight against the iatrogenic effects of drugs.
Service de pharmacie clinique, groupe hospitalier Necker-Enfants-Malades, 149 rue de Sèvres, Paris cedex 15, France. philippe.bourget@nck.aphp.fr
P
P
Bourget
A
A
Amin
A
A
Moriceau
B
B
Cassard
F
F
Vidal
R
R
Clement
D018943:Anthracyclines / Q000032:analysis*; D000970:Antineoplastic Agents; D002851:Chromatography, High Pressure Liquid; D004317:Doxorubicin / Q000032:analysis; D015251:Epirubicin / Q000032:analysis; D006801:Humans; D007267:Injections; D004364:Pharmaceutical Preparations / Q000032:analysis; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions; D017550:Spectroscopy, Fourier Transform Infrared; D013059:Spectrum Analysis, Raman / Q000379:methods*
D018943:Anthracyclines; D000970:Antineoplastic Agents; D004364:Pharmaceutical Preparations; D012996:Solutions; D015251:Epirubicin; D004317:Doxorubicin