Abstract:
The present study aimed to develop and validate a novel reversed-phase high-performance liquid
chromatography method for simultaneous estimation of Diacerein (DIA) and Rhein (Rh, alkaline
degradation product and active metabolite) in the presence of various coformers used to prepare
eutectic oral formulation. Chromatographic separations were achieved on a Phenomenex Gemini
C18 column (250 mm × 4.6 mm, 5 μm) placed in the thermostated column oven at 40◦C. The
mobile phase, comprising of acetonitrile and 10 mM ammonium acetate (pH 3.0), was eluted
through the gradient system with 0.8 mL/min flow rate at 254 nm detection and analytical run
time of 14 min. Additionally, the method was validated for specificity, linearity, precision, accuracy,
selectivity, limit of quantitation, limit of detection and robustness as per International Conference
on Harmonization guideline. The developed methodwas applied for the comparison of drug release
profiles of pure DIA and from prepared eutectic formulations for the quantitation of DIA and Rh in
the multicomponent adducts. The achieved method advocated their applicability in routine quality
control analysis of DIA formulations without interference of degraded product and excipients.
