O.Yu. Аrshinova, E.V. Ignatieva, N.A. Oborotova

In medical practice a heightened interest towards the use of chlorine derivatives as photosensitizers (PHS) for photodynamic therapy (PDT) of tumors and other pathologies is marked. Fotoditazin is one of the best PHS in this group, its efficacy is consistently proved in a course of preclinical and clinical tests. Fotoditazin possesses high coefficient of accumulation selectivity in tumor in relation to normal tissues, the big quantum efficiency that provides high degree of phototoxicity. It is quickly deduced from an organism. Fotoditazin is produced in the form of concentrate for infusion solution preparation (5 mg/ml), and also in the form of 0,5 % gel-penetratora for external application. The research and study of PHS-s properties have led to working out lyophilized drug form. Despite available publications in the field of the lyophilized preparation analysis, the major part of works on their standardization has private character. The creation of quality control strategies of lyophilized drug forms for intravenous injections is an actual problem. The present article is devoted to working out the thin-layer chromatography and spectrophotometry methods. With the help of spectrophotometric analysis it is possible to define quantitatively the maintenance of fotoditazin in lyophilized drug form, and also it is possible to prove its authenticity (characteristic electronic spectrum of fotoditazin alcoholic solution: (400±2) нм, (504±2) нм, (534±2) нм, (608±2) нм, (662±2) нм, (460±2) нм, (522±2) нм, (578±2) нм, (624±2) нм). The presence of N-methylglucamin in the drug form is proved by use of thin-layer chromatography method (the stain of dark brown color should be detected at stain level (Rf nearby 0,13) of witness solution). In the given research the choice of methods of analysis carried out by taking into an account physicochemical properties of fotoditazin.