Contrôle de qualité des antibiotiques dans la Pharmacopée Européenne : évolution récente dans le cas des aminosides

Aminoglycosides constitute a particular class of antibiotics presenting aminoglycoside moieties linked to a central aminocyclitol ring. Several aminoglycosides are described by a monograph in the European Pharmacopoeia. The related substances test is used to check for impurities. For this purpose, thin layer chromatography is now being replaced by high performance liquid chromatography. In the case of aminoglycosides the main challenge is the detection of these compounds since they do not possess a chromophore in their structure. Different possibilities are proposed in the monographs. Amikacine is detected at 340 nm after pre-column derivatization. In more recent monographs, pulsed amperometry detection is proposed. However, this mode of detection requires skilful manipulations. Evaporative light scattering detection could be a valuable alternative. The advantages and drawbacks of each approach will be discussed.