Wzgarda Anna, Dettlaff Katarzyna, Rostalska Martyna, Pabian Ewa, Regulska Katarzyna, Stanisz Beata Jadwiga
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan Unversity of Medical Sciences, 6 Grunwaldzka St., 60-780 Poznan, Poland.
The Oncology Center of Wielkopolska, 15 Garbary St., 61-866 Poznan, Poland.
Iran J Pharm Res. 2017 Summer;16(3):1007-1018.
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 t. PER should be stored in closed containers, protected from high temperature and moisture. PER is referred to be photostable and resistant for radiodegradation.
本研究的主要目的是测定培哚普利叔丁胺盐（PER）的热稳定性、辐射稳定性和光稳定性，从而维持治疗的有效性和安全性。在使用前已验证一种色谱方法（反相高效液相色谱法）以测定PER的损失。研究了在等温条件、相对湿度-RH = 0%和76.4%、暴露于600万勒克斯·小时以及25 - 400千戈瑞电子束产生的电离辐射影响下，PER在固态下的稳定性特性。研究指出，水分的存在会改变PER降解的动力学模型；空气中缺乏水分会产生反应的一级动力学模型，湿度增加会产生自催化模型。PER被证明对电离辐射具有抗性。可以使用辐射灭菌和去污（剂量25千戈瑞）而不会使含量有显著损失。对PER光稳定性的研究证明，在暴露于600万勒克斯·小时后，理化参数是可接受的。在所有血管紧张素转换酶抑制剂中，PER的半衰期最短。PER应储存在密闭容器中，防止高温和潮湿。PER被认为具有光稳定性且抗辐射降解。
