Determination of Sulphasalazine and Its Related Compounds by Simple, Smart, Validated, Green Spectrophotometric Methods

Abstract

Background: Sulphasalazine (SZ) is a prodrug. Its active metabolite (mesalazine, MZ), which is also available in pharmaceutical formulations, and the major active metabolite of MZ (N-acetyl-5-aminosalicylic acid, AS) are commonly used for the treatment of inflammatory bowel diseases.

Objective: Two accurate, precise, sensitive, and specific spectrophotometric methods were developed and validated for determination of the studied components.

Methods: The first method is a modified ratio difference spectrophotometric method. In this method, SZ was determined by measuring the peak area from 410-500 nm, while MZ and AS were determined by measuring the difference of the selected amplitude values. The second method is a mean centering of ratio spectra spectrophotometric method.

Results: The developed methods were linear over the concentration ranges of 2-35, 2-30 and 1-25 µg/mL for SZ, MZ and AS, respectively.

Conclusion: The developed methods were validated according to International Conference on Harmonization guidelines. They were successfully applied for determination of studied analytes. A greenness assessment was undertaken using three different tools.

Highlights: Spectrophotometric methods were developed for determination of SZ and its related compounds for the first time. They were designated to be green and eco-friendly and their greenness profiles were evaluated using green solvents to keep the environment clean.