Forced Degradation Studies Of Pimecrolimus As Per ICH Guidelines

Forced degradation studies are used to validate analytical procedures for the drug substance and degradation products. Forced degradation studies of Pimecrolimus drug substance and its cream were performed under the stressed alkaline, acidic, oxidative and thermal conditions according to ICH guidelines ICH Q1A(R2). A sensitive stability indicating RP-HPLC method was purposed and validated for the separation of Pimecrolimus and Desmethyl Pimecrolimus. The chromatographic separation was achieved with Phenomenax Luna, C18, 150 x 4.6mm and 3µm particle size column. The flow rate was 1.5 mL/min and eluents were detected at 210nm using PDA detector. For the examination of Pimecrolimus and its associated compounds, our newly designed HPLC approach proved extremely exact, specific, reliable, and accurate.