Stability Indicating Method for Eluxadoline B...

Stability Indicating Method for Eluxadoline By HPTLC

Author Name : Mrinalini C. Damle, Pooja P. Lanke

ABSTRACT

Eluxadoline is the drug used to treat irritable bowel syndrome disease. A High-Performance Thin Layer Chromatographic method has been developed for Eluxadoline. A simple and precise method was optimized for Eluxadoline by using Ethyl Acetate: Methanol: Triethylamine as a mobile phase in the ratio of 5:5:0.1 v/v/v. The retardation factor was found to be 0.45±0.02. Detection was carried out at 238 nm. The linear regression analysis was checked in the range of 200–1000 ng/band concentrations with regression coefficient 0.9953. The accuracy of the method was established based on the recovery studies. The LOD and LOQ were 49.54 and 150.12 ng/band respectively. Stress degradation conditions like hydrolysis under different pH conditions, photolytic degradation, thermal degradation and oxidation degradation was performed as per ICH Q1A(R2) and Q1B guidelines. The drug was found to be susceptible to all stress conditions.

Keywords:  Eluxadoline, HPTLC, Stability indicating, validation