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

Abstract

The main aim of this study was determination of thermo- radio- and photostability ofperindopril tert-butyloamine (PER) therefore the efficiency and safety of the therapy could bemaintained.A chromatographic method (RP-HPLC) had been validated before use to determinePER loss. The evaluation of stability properties of PER in solid state under the influence ofisothermal condition, relative humidity - RH = 0% and 76.4%, exposure to 6 mln lux h andionizing 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, increasehumidity generates the autocatalytic model. PER proved to be resistant for ionizing radiation. Itis possible to use radiation sterilization and decontamination (dose 25 kGy) with no significantloss of content. Investigation of PER photostability proved, that after exposure to 6 mln lux hphysicochemical parameters are acceptable. Among all the ACE-I, PER has one of the shortestt0,5. PER should be stored in closed containers, protected from high temperature and moisture.PER is referred to be photostable and resistant for radiodegradation.