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Sci. Pharm. 2014, 82(2), 295-306; doi:10.3797/scipharm.1311-15

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

Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala – 147002, India
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Received: 22 November 2013 / Accepted: 12 January 2014 / Published: 12 January 2014
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Abstract

Sulfasalazine (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.
Keywords: Sulfasalazine; Forced degradation; HPLC; ICH; Stability-indicating Sulfasalazine; Forced degradation; HPLC; ICH; Stability-indicating
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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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.

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