Thermo-, Radio- and Photostability of Perindopril Tert-butyloamine in The Solid State. Comparison to Other Angiotensin Converting Enzyme Inhibitors

The main aim of this study was determination of thermo- radio- and photostability of perindopril tert-butyloamine (PER) therefore the efficiency and safety of the therapy could be maintained. A chromatographic method (RP-HPLC) had been validated before use to determine PER loss. The evaluation of stability properties of PER in solid state under the influence of isothermal condition, relative humidity - RH = 0% and 76.4%, exposure to 6 mln lux h and ionizing radiation generated by beam of electrons of 25–400 kGy was investigated. Studies pointed out that presence of moisture changes a kinetic model of PER degradation; lack of moisture in the air generates a first-order kinetic model of the reaction, increase humidity generates the autocatalytic model. PER proved to be resistant for ionizing radiation. It is possible to use radiation sterilization and decontamination (dose 25 kGy) with no significant loss of content. Investigation of PER photostability proved, that after exposure to 6 mln lux h physicochemical parameters are acceptable. Among all the ACE-I, PER has one of the shortest t0,5. PER should be stored in closed containers, protected from high temperature and moisture. PER is referred to be photostable and resistant for radiodegradation.