Immunochemical method for sulfasalazine determination in human plasma

Area of Science:

• Pharmacology
• Analytical Chemistry
• Immunology

Background:

• Sulfasalazine is a key antibiotic for treating inflammatory bowel diseases.
• Monitoring drug levels is crucial for effective and safe patient treatment.
• Existing methods for sulfasalazine assessment may lack sensitivity or specificity.

Purpose of the Study:

• To develop and characterize a highly sensitive and specific Enzyme-Linked Immunosorbent Assay (ELISA) for sulfasalazine.
• To validate the ELISA method for quantifying sulfasalazine in biological matrices, specifically human plasma.
• To establish a tool for facilitating patient monitoring and personalized dosing of sulfasalazine.

Main Methods:

• Development of a polyclonal antibody-based Enzyme-Linked Immunosorbent Assay (ELISA).
• Characterization of the immunoassay's sensitivity, specificity, detection limit, and dynamic range.
• Validation using spiked human plasma samples after protein precipitation with methanol.

Main Results:

• The developed ELISA demonstrated high sensitivity (IC50=0.51 ng mL(-1)) and specificity.
• A low detection limit of 0.02 ng mL(-1) and a dynamic range of 0.06-3.75 ng mL(-1) were achieved.
• Excellent recoveries (83-119%, mean 99%) were observed in spiked plasma samples, indicating method reliability.

Conclusions:

• The validated ELISA method is suitable for the accurate determination of sulfasalazine in human plasma.
• The assay's performance supports its application in clinical settings for patient monitoring.
• This tool can aid in optimizing sulfasalazine therapy through personalized dosage adjustments.