Stability-indicating method based on liquid chromatography for investigation of pharmaceutical substances and pharmaceutical preparations

The stability - indicating method is an analytical procedure used to detect a decrease in the amount of an active pharmaceutical ingredient present due to degradation. According to FDA guidelines, stability - indicating method is defined as a validated analytical procedure that accurately and precisely measures active ingredients free from potential interferences like degradation products, process impurities, excipient or other potential impurities. During stability studies, liquid chromatography is used routinely to separate and determine the analyses of interest. For implementing the stability - indicating method, several steps are needed. An active pharmaceutical substance is firstly subjected to the forced degradation studies followed with the investigations of its interactions with the excipient from the pharmaceutical preparation, the optimization of chromatographic conditions and the method validation.