DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF IGURATIMOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

Objective: The objective of the work was to develop and validate stability indicating HPTLC method for estimation Iguratimod. Methods: employed aluminium pre-covered silica gel 60 GF254 plates (10 cm × 10 with 250 μm layer thickness) as stationary phase while solvent system n-Hexane: Ethyl Acetate (5:5 v/v) densitometric scanning at 256 nm. Sample applied a band 8 mm width using Camag 100 μl sample syringe (Hamilton, Switzerland) linomat 5 applicator (Camag, Switzerland). Migration distance 80 mm. Further subjected stress conditions under acid base hydrolysis, oxidation, thermal, neutral photolytic conditions. Method validation done according ICH Q2 (R1) guidelines. Results: Retention factor (Rf) drug 0.41±0.02. linearity found be within concentration range 200-1200 ng/band R2= 0.983. Limit detection limit quantification were 34.69 105.12 respectively. % mean recovery 100.38±0.83. Stress results showed that there is degradation in but two degradant peaks observed only alkaline condition Conclusion: developed accurate, simple precise. successfully various