Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing
AbstractSulfasalazine (SSZ) was subjected to degradation under the conditions of hydrolysis (acid, alkali, and water), oxidation (30% H2O2), dry heat, and photo-lysis (UV-VIS light) in accordance with the ICH guidelines. An RP-HPLC method was developed to study the degradation behavior. No degradation was noted under any condition except alkaline hydrolysis where SSZ was degraded to a single minor product. SSZ was optimally resolved from this product on an XTerra® RP18 column with a mobile phase composed of methanol and an ammonium acetate buffer (10 mM, pH 7.0) (48:52, v/v) delivered at a rate of 0.8 mL/min in an isocratic mode. The method was validated and found to be linear (r2=0.99945), precise (%RSD <2), robust, and accurate (94–102%) in the concentration range of 0.5–50 μg/mL of SSZ. The PDA analysis of the degraded sample revealed the SSZ peak purity to be 998.99 and the drug peak eluted with a resolution factor of >2 from the nearest resolving peak, indicating the method to be selectively stability-indicating for the drug analysis. The method was applied successfully for the stability testing of the commercially available SSZ tablets that were under varied ICH-prescribed conditions. An explanation for the unusual stability of the drug when exposed to acidic hydrolysis, despite the presence of the sulfonamide linkage, is also discussed.
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SAINI, B.; BANSAL, G. Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing. Sci. Pharm. 2014, 82, 295-306.
SAINI B, BANSAL G. Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing. Scientia Pharmaceutica. 2014; 82(2):295-306.Chicago/Turabian Style
SAINI, Balraj; BANSAL, Gulshan. 2014. "Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing." Sci. Pharm. 82, no. 2: 295-306.