Forced Degradation Studies Of Pimecrolimus As Per ICH Guidelines

Abstract

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.