The influence of stress factors on dioxoindolinone stability
Introduction
Stability studies for pharmaceutical products represent a primary stage in the development and manufacture of a new medicinal product, being a fundamental condition that guarantees its quality and efficacy. The research was initiated with the aim of the determining the stability of Dioxoindolinone under stress conditions in order to find out the factors that can induce possible changes in the molecular structure of the Dioxoindolinone, which consequently can lead to a partial or total diminution of the therapeutic effect.
Materials and methods
In the experimental research, Dioxoindolinone was used, synthesized in the Organic Synthesis Laboratory of the Institute of Chemistry, at USM, (purity 99.9%). The following apparatus was used: analytical balance (OHAUS DV215 CD, Switzerland); spectrophotometer (Shimadzu UV-1800, Japan); a pair of quartz cuvettes with a layer thickness of 10 mm; ultraviolet lamp chamber (UV with CN-6 filter, France) for exposure to 254 nm and 365 nm radiation; thermostat (TC-80M-2, Ukraine) set at 60 ± 1°C; ultrasonic bath (Sapfir, St. Petersburg); reagents: analytical grade reagents – 0.1 M hydrochloric acid (HCl) (ChemLab, Belgium); 0.1 M sodium hydroxide (NaOH) (ChemLab, Belgium); 3% hydrogen peroxide solution (H2O2) (CentroChem, Poland); ethanol (96%) (CentroChem, Poland).
Results
The influence of stress factors, such as oxidants, acids, bases, humidity, high temperatures and UV irradiation on the stability of Dioxoindolinone was studied. Under conditions of oxidative, hydrolytic, thermal, acid-base, photolytic stress by the UV-Vis spectrophotometric method it was determined that the substance is stable to humidity and in the acidic environment. Dioxoindolinone degrades under the influence of oxidant, it was found to be unstable in the basic environment (a change in concentration was observed). The insignificant influence of UV light and high temperature was demonstrated.
Conclusions
The influence of stress factors on the stability of Dioxoindolinone was studied. The results obtained will be used to establish optimal storage conditions that will be introduced in the Quality Standardization Specification for Dioxoindolinone.