Photolability evaluation of the new cytostatic drug mitonafide

A qualitative and quantitative study on the stability of the new cytostatic drug mitonafide (N-[2-(dimethyl-amino) ethyl]-3-nitronaphthalimide, CAS 54824-17-8) against UVA, UVC and visible radiations was carried out. Initially a test with controlled lighting on samples from mitonafide solution is carried out. This test include the determination of the protector effect of different kinds of glasses (clear and amber glass). The results achieved are verified by means of a test in normal lighting conditions (direct sun light, normal laboratory lighting and darkness). High mitonafide photodecomposition, deeper against UVA radiation, requires conservation of raw material in darkness. Similarly UV sterilizing radiations must be avoided in sterile rooms during manufacture. The use of amber glass ampoules is not enough to protect parenteral solutions from radiations. Direct sunlight must be avoided in the manufacture, control tests and administration in perfusion of pharmaceutical dosage forms, although artificial light can be used during short periods of time.