A simple, sensitive, and accurate stability indicating HPTLC method has been developed and validated for estimation of Seratrodast in bulk and pharmaceutical dosage form. The drug was spotted on precoated silica gel 60 F254 aluminum plates using Toluene: Methanol: Glacial acetic acid (8.5:1:0.5 v/v/v) as mobile phase. The retention factor (Rf) was found to be 0.52 ± 0.04. The detection of band was carried at 266 nm. The drug was subjected to different stress conditions like acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 100-600 ng/band concentrations with correlation coefficient 0.994. The accuracy of the method was established based on the recovery studies.

The developed method was found to be simple, sensitive, selective, accurate, and repeatable for analysis of Seratrodast and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form