Abstract

DEVELOPMENT OF NEWER ANALYTICAL METHODS FOR THE ESTIMATION OF DIACEREIN IN SOLID DOSAGE FORMS

C. G. Jincy and U. S. Jijith*

Abstract

Diacerein, an interleukin-1 beta inhibitor, is widely used in osteoarthritis treatment due to its anti-inflammatory and cartilageprotective properties. Despite its therapeutic significance, limited analytical methods exist for its estimation in pharmaceutical formulations. This study aimed to develop and validate two simple, accurate, and reproducible analytical methods: UV spectrophotometry and high-performance liquid chromatography (HPLC) with gel permeation chromatography (GPC) columns. The UV spectrophotometric method was developed using 0.01N NaOH, measuring absorbance at 236 nm, and demonstrated linearity within 2- 10 μg/mL. The HPLC method utilized tetrahydrofuran as the mobile phase and exhibited excellent sensitivity (LOD: 0.5 μg/mL, LOQ: 1 μg/mL). Both methods were validated as per ICH guidelines and compared with existing methods. The developed techniques provide reliable options for routine quality control of diacerein in pharmaceutical dosage forms.

Keywords: Diacerein, UV spectrophotometry, HPLC, Gel Permeation Chromatography, Analytical Method Development, Validation.