• Ravindra Bhaskar Nehete
• Dr. Pushpendra Sharma

The present study describes a simple and stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantification of the related substances of Iguratimod drug substance. Successful separations of the possible impurities were achieved on a Inertsil ODS-3 (150 × 4.6 mm, 5μm) and UV detector at 257nm, 0.8mL/min as a flow rate, and 20μL as an injection volume. For mobile phase-A preparation, 5.44gm potassium dihydrogen orthophosphate dissolved in 2 liter water and adjusted pH 4.00±0.05 with dilute orthophosphoric acid and filter through 0.45µ membrane filter. Use HPLC grade Acetonitrile as mobile phase-B. Use gradient flow program with column temperature 40°C. Percentage recovery obtained in the range of 80-120% and the method is linear for all possible impurities and Iguratimod for specified concentration range with coefficient of variation (r) not less than 0.99. Acid, base, peroxide and thermal degradation were carried in drug substance. The proposed RP- HPLC method was found to be specific, linear, precise, accurate and robust.

Iguratimod, validation, development, stability indicating methodology.

"Development and Validation for related substances in Iguratimod", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.5, Issue 3, page no.151-157, March-2018, Available :http://www.jetir.org/papers/JETIR1803032.pdf

"Development and Validation for related substances in Iguratimod", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 3, page no. pp151-157, March-2018, Available at : http://www.jetir.org/papers/JETIR1803032.pdf