Raman Spectroscopy: an ultra-rapid and non-destructive solution for Analytical Quality Control of injectable solutions, and its application to oxazaphosphorins

Bruno Cassard1, Rozenn Clément1, Patrice Prognon2, Philippe Bourget1 1 Service de Pharmacie Clinique, Hôpital Necker - Enfants Malades
2 Service de Pharmacie Clinique, Hôpital Européen Georges Pompidou, France

The establishment of Centralised Production Units for Injectable Drugs in hospitals means that it is of great importance that we also create suitably effective Analytical Quality Control (ACQ) tests for drug identity, purity and concentration. Raman Spectroscopy (RS) is a vibration analysis technique which allows for direct, rapid and non-destructive analysis of a number of types of chemical through the primary packaging of Therapeutic Items (TIs).

The aim of this study is to evaluate the feasibility of implementing an AQC system for chemotherapies using RS applied to ifosfamide (IFM) therapies.

Analysis was carried out using an RXN1 Raman Spectrometer (Kaiser Optical Systems) fitted with a LASER emitting source of 785nm. The IFM ranges (1-5-10-15-20 mg/ml), quality controls (2-8-16 mg/ml) and the TIs in polyolefin pouches (2-4-6 mg/ml) were fabricated in NaCl 0.9% and G 5%. The results were compared to those obtained using the CLHP-UV method. The specificity of the spectral signature was established in relation to cyclophosphamide (CPM).

Results: Two principal vibration bands of 660 and 752 cm-1 were isolated for IFM. The scales observed were linear in their intervals of retained concentrations (r2=0.99). This technique offers a satisfactory level of fidelity (CV<10%) and precision > 95%. We demonstrated a strong correlation between the concentrations measured by RS and by CLHP (p < 0.001). IFM and CPM both present characteristic RS spectral profiles, which is attributable to a good level of analytical specificity.

These results demonstrate the great potential of RS for the designated task of AQC testing of chemotherapy products. Analysis of IFM therapeutic solutions by RS is simple to establish, non-destructive, very rapid and very safe for the operators involved. This new analytical technique could make a serious contribution to enhancing the security of the drug preparation and delivery cycle.

Diapos-La Spectroscopie Raman Diapos-La Spectroscopie Raman

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