Abstract
Analytical method with accuracy, precision and stability indicting was developed for Iguratimod, achieved the required chromatographic separation by High pressure liquid chromatography (HPLC) techniqu e. HPLC method with accuracy, precision, robustness and stability indicating was developed and optimized for quantitative evaluation of Iguratimod as active pharmaceutical ingredient. Chromatographic separation for Iguratimod and its related compounds was achieved by using analytical column with stationary phase Inertsil ODS-3 (Dimension: length 150mm, internal diameter 4.6mm and particle size 5µ) and mobile phase (Buffer and acetonitrile in gradient proportion) at flow rate 1.0ml/minute with detection at 257nm. Squared correlation coefficient (r2) was observed more than 0.999 with concentration window of 12.5 to 75µg/ml. Iguratimod was retained at about 19.0±2.0 minutes. Forced degradation study for Iguratimod was carried out under the stress condition to get required degradation by using acid, base, thermal, photolytic and oxidation by hydrogen peroxide. Degradation products which are generated during stress condition did not interfere to active ingredient, Iguratimod. This analytical method optimized, validated for all the parameters specified in ICH guideline, to get results selective, accurate and precise in presence of degradation impurities.
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