Hydrophilic interaction liquid chromatography method for eremomycin determination in pre-clinical study

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science
• Chromatography

Background:

• Eremomycin (ERM) is an active pharmaceutical ingredient (API) in a novel drug requiring preclinical evaluation.
• Existing methods may face interferences from drug matrix components like polyethylene glycol (PEG).
• Development of robust analytical methods is crucial for drug development and preclinical studies.

Purpose of the Study:

• To develop and validate simple and efficient hydrophilic interaction liquid chromatography (HILIC) methods for determining eremomycin (ERM).
• To assess the drug's dissolution profile and pharmacokinetic behavior in preclinical animal studies.
• To evaluate a novel home-made HILIC stationary phase for ERM analysis.

Main Methods:

• Synthesis of a home-made HILIC silica-based stationary phase with diol and positive nitrogen functionalities.
• Development of a HILIC method for dissolution testing, avoiding PEG interference.
• Validation of a HILIC-MS/MS method for ERM determination in rabbit plasma according to EMA guidelines.

Main Results:

• The home-made HILIC stationary phase showed superior performance compared to commercial columns.
• The HILIC method effectively resolved ERM from PEG in the drug matrix.
• Pharmacokinetic studies in rabbits indicated low ERM bioavailability after administration.

Conclusions:

• The developed HILIC methods are suitable for the preclinical evaluation of the novel ERM-containing drug.
• The novel home-made stationary phase offers advantages over traditional methods for ERM analysis.
• Findings suggest potential safety and efficacy of the novel drug, warranting further investigation.