Use of validated stability-indicating chromatographic methods for quantitative analysis of idrocilamide in a pharmaceutical formulation

摘要

Two sensitive and selective chromatographic methods have been developed and validated for analysis of idrocilamide in the presence of its degradation products. Forced degradation studies were performed using HCl, NaOH, and 3% H ~2 O ~2. The first method is based on thin-layer chromatographic separation of the intact drug from its degradation products, followed by densitometric measurement. The second method is based on isocratic reversed phase high-performance liquid chromatographic separation of the drug from its degradation products on a C ~(18) column. The HPLC method was used to investigate the kinetics of alkaline degradation of the drug at different temperatures.