Gadoterat Meglumin’in Bozunma Ürünlerinin Varlığında Yüksek Basınçlı Sıvı Kromatografisi ile Analizleri

Abstract

Gadolinium contrast agents are chemicals used in magnetic resonance imaging. When injected into the body, gadolinium contrast agent enhances and improves the quality of magnetic resonance imaging. These substances are commonly used in magnetic resonance imaging as they allow more accurate reporting of how our body whether there are any diseases or abnormalities. In this study, high performance liquid chromatography method was developed and validated for the analysis of active substance and its impurities in the solution for injection containing gadoterate meglumine, which is a gadolinium contrast agent. Analysis of the gadoterate meglumine active substance, its impurities and degradation products formed by the exposure of its pharmaceutical formulations, to different stress conditions were carried out by the developed HPLC method. The optimum conditions in the developed HPLC method; on Phenomenex Luna Phenyl-Hexyl column (250 x 4.6 mm, 3 μm column), flow rate of 0.4 mL/min and UV wavelength of 200 nm. was obtained. Gradient program was applied using as 40 mM phosphate buffer (pH = 4.3) mobile phase A, 40 mM phosphate buffer (pH = 4.3): acetonitrile (90 : 10, v/v) mobile phase B. The sampler temperature was adjusted to 4°C in order to ensure the solution stability of the samples. In the developed analytical method, by applying stress studies (acid, base, peroxide, heat and light decomposition) to the pharmaceutical formulation and placebo, possible degradation products were determined. The developed analytical method was validated by applying the parameters of selectivity, linearity, accuracy, precision, sensitivity, stability and robustness. It has been suggested that this developed and validated method can be used for analysis of gadoterate meglumine active ingredient and related to DOTA and DO3A impurities. This validated chromatographic method was successfully applied to the its pharmaceutical preparation containing gadoterate meglumin and its impurities.