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

Abstract

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