Hplc Method Development and Validation of Iguratimod Tablet Dosage Form

Abstract

Objective: A simple, rapid, linear, accurate, precise & robust method was developed & validation method was developed for Iguratimodtablet dosage form as per ICH (International Council for Harmonization) guidelines Q2R (1).Methodology: Chromatographic evaluation was carried out on C18 column with wavelength of 257nm using mobile phase of Acetonitrile: Methanol (50:50 v/v). Flow rate was maintained to 1ml/min. Results: The retention time was obtained to be 2.7 minutes throughrun time of 6 minutes. The validated method was applied by several validation parameters like Specificity, Linearity (calibration curve), Precision, Accuracy, Robustness, LOD &LOQ.The correlation coefficient of Iguratimod tablet was found to be 0.9998 when the concentration in the range of 10-50μg/mlwere used indicated good linearity. The average percentage of recovery was 100-102%. This indicates that the developed method is accurate.The %RSD for precision study obtainedas0.494377 (Intraday) & 0.535898 (Interday) that are within acceptance limit (NMT 2%) indicatesthat the developed method is precise. The LOS and LOQ wasobtained as 0.118μg/ml and 0.358μg/ml respectively. Conclusions: The validated method can be used for estimation of Iguratimod inTablet dosage form for routine analysis work.