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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(2):295-306doi: 10.3797/scipharm.1311-15.
Saini, B., & Bansal, G. (2014). Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing. Scientia pharmaceutica, 82(2), 295-306. https://doi.org/10.3797/scipharm.1311-15
Saini, Balraj, and Bansal, Gulshan. "Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing." Scientia pharmaceutica vol. 82,2 (2014): 295-306. doi: https://doi.org/10.3797/scipharm.1311-15
Saini B, Bansal G. Degradation Study on Sulfasalazine and a Validated HPLC-UV Method for its Stability Testing. Sci Pharm. 2014 Jan 12;82(2):295-306. doi: 10.3797/scipharm.1311-15. Print 2014. PMID: 24959403; PMCID: PMC4065124.
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Sci Pharm. 2014 Jan 12;82(2):295-306. doi: 10.3797/scipharm.1311-15. Print 2014.

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

Scientia pharmaceutica

Balraj Saini, Gulshan Bansal

Affiliations

  1. Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala - 147002, India.

PMID: 24959403 PMCID: PMC4065124 DOI: 10.3797/scipharm.1311-15

Abstract

Sulfasalazine (SSZ) was subjected to degradation under the conditions of hydrolysis (acid, alkali, and water), oxidation (30% H2O2), dry heat, and photolysis (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 (r(2)=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: Forced degradation; HPLC; ICH; Stability-indicating; Sulfasalazine

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