Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IGURATIMOD IN TABLETS

Pardeshi Sweta Nareshbhai* and Hiral Panchal

ABSTRACT

The present study describes a simple and stability indicating high performance liquid chromatography (HPLC) method for the quantification of the related substances of iguratimod drug substance. Successful separation of the possible impurities were achieved on a Thermo C18 (150mm×4.6mm, 5μm) and UV detector at 265nm, 1.0 ml/min as a flow rate and 20μl as an injection volume. Mobile phase (methanol: buffer (pH 3.0±5.0): ACN (10:50:40%V/V/V) Column temperature 25°C percentage recovery obtained in the range of 98.0-102.0% and the method is linear for all possible impurities and Iguratimod for specified concentration range with coefficient of variation not less than 0.99. Acid, base, oxidative and thermal degradation were carried in drug substance. The proposed HPLC method was found to be specific, linear, precise, accurate and robust. (Buffer- 13.6 gm of potassium dihydrogen phosphate into 1000 ml water and adjust pH 3.0±5.0 with 0.1% orthophosphoric acid.)

Keywords: Iguratimod, Validation, Development, Stability indicating method.