High‐Speed Liquid Chromatographic Analysis of Sulfasalazine (Salicylazosulfapyridine)

Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing

“…The International Conference on Harmonization (ICH), through its guidelines Q1A (R2) and Q1B [10, 11], requires the conduct of forced degradation studies to characterize all of the possible degradation products under varied conditions such as light, heat, humidity, acid/base hydrolysis, and oxidation in order to develop a stability-indicating assay method (SIAM) for the stability testing of a drug substance or product. An extensive literature search has revealed that several analytical methods were reported in the 1990s for the analysis of SSZ alone [12, 13], in the formulations [14], and in the presence of metabolites [15–21]. Peel et al, 1994 [22] and Coward et al, 1995 [23] had reported interference of SSZ with the HPLC assay of urine and 5-hydroxyindole-3-acetic acid, respectively.…”

Characterization of Impurities in Sulfasalazine

“…Sulfasalazine is prepared by diazotizing sulfapyridine and coupling the diazotized intermediate with salicylic acid (4, 5). The common analytical procedures used for sulfasalazine are titration with titanium trichloride (6), polarography (7), spectrophotometry (6), and high-speed liquid chromatography (8). All procedures are specific for pure sulfasalazine; but in the presence of unknown impurities, these methods are questionable.…”

High-Performance Liquid Chromatographic Assay of Sulfapyridine and Acetylsulfapyridine in Biological Fluids

“…HPLC was used in measuring I in tablets and powders (8). Sharma et al (9) measured various sulfas and acetyl metabolites in animal urine by HPLC.…”