Abstract

STRESS STABILITY STUDY SHOWING EFFECT of ACID, BASE, H2O2 AND DRY HEAT ON GLIMEPIRIDE BY HPTLC METHOD

Deepak Pokharkar*, Dr. Chandra Kishore Tyagi

Abstract

Forced degradation studies include degradation of drug substances and drug products at conditions more severe than accelerated conditions. These studies illustrate the chemical stability of molecule which further facilitates the development of stable formulation with suitable storage conditions. Glimepiride belongs to class of second generation sulfonyl urea used to treat type –II diabetes mellitus. It lowers blood sugar by stimulating the release of insulin by pancreatic beta cells and by inducing increased activity of intracellular insulin receptors. Degradation products of Glimepiride formed under different forced conditions have been characterized through (High Performance Thin Layer Liquid Chromatography) HPTLC studies. The method was developed using TLC silica gel 60 F254 aluminum backed plate as the stationary phase and Toluene: Chloroform: Ethanol 4:4:1 v/v/v as Mobile phase taking absorbance at 234nm. The forced degradation study was carried out in accordance with the (International Conference Of Harmonization) ICH guidelines Q1A (R2) for Glimepiride in oxidative condition 6% Hydrogen peroxide for 3 hours, in acidic condition 0.1M HCl at 80˚C for 60 Minutes, in basic condition 0.1M NaOH at 80˚C for 60min and in thermal condition 60˚C for 3 hours. Degradation products were well separated by proposed method.

Keywords: Glimepiride, Degradation studies, HPTLC, Accelerated conditions, ICH.