ArticlePloS one2026
Purification and pharmacokinetic study of gadoxetate isomers for enhanced rabbit liver MR imaging.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
This study aimed to purify and prepare two isomers of Gadoxetate (Gd-A and Gd-B) from Pumexian and evaluate their stability, magnetic resonance (MR) imaging characteristics, and pharmacokinetics in rabbits. Reversed-phase liquid chromatography was employed to separate Gd-A and Gd-B, achieving purities exceeding 99% for both isomers. These purified isomers were then processed into vacuum-encapsulated solid powders via nitrogen blowing and freeze-drying. Stability assessments were conducted by storing the powders at various temperatures (25°C, -20°C, 50°C, and 80°C) for two months. The results indicated high stability at room temperature (25°C) and low temperature (-20°C), with both Gd-A and Gd-B maintaining 99% purity. At higher temperatures, purity slightly decreased: Gd-A was 98% at 50°C and 95% at 80°C, while Gd-B was 97% at 50°C and 94% at 80°C. For the in vivo evaluation, twelve rabbits were randomly assigned to two groups and received intravenous bolus injections of either pure Gd-A or Gd-B, followed by enhanced MR scanning and serial blood sampling. Pharmacokinetic and imaging analyses revealed statistically significant differences (p < 0.05) between the two isomers. Specifically, Gd-A exhibited a shorter time to peak enhancement in liver parenchyma (tpeakA < tpeakB), higher peak signal intensity in the liver parenchyma (SIpeakA > SIpeakB), greater plasma clearance (PCL-A > PCL-B), and a shorter half-life (t1/2A < t1/2B) compared to Gd-B. In conclusion, the vacuum-encapsulated solid powders of Gd-A and Gd-B demonstrate good long-term stability at room or low temperatures while maintaining high purity. Furthermore, the distinct pharmacokinetic profile and imaging characteristics of pure Gd-A suggest its potential value for clinical applications.
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