Liquid chromatographic determination of sulfasalazine in tablets and bulk powder.

A liquid chromatographic method has been developed that determines the amount of sulfasalazine in tablets and bulk powder in the presence of residual synthesis by-products and excipients. The method was tested on crude product containing large amounts of impurities. A C-18 reverse phase column with water-acetonitrile-acetic acid mobile phase was found to effectively separate the drug on the column. Six different commercial samples of 500 mg tablets were assayed. The results varied from 92.6 to 101.8% of the declared amount. Spectrophotometric determinations, which do not discriminate between the drug and impurities, gave 95.4-101.8% of declared. One commercial sample of bulk powder was assayed.