Forced Degradation Studies of Stigmasterol: Development of Stability Indicating Hptlc Method and I’ts Validation as Per Ich Guidelines

Abstract

Background - Forced degradation is a method for determining the stability of pharmaceuticals so that stable formulations can be developed & the shelf life of pharmaceuticals can be predicted. During force degradation studies in pharmaceuticals, this research describes the characterization of generated contaminants and mechanism of formation. Forced degradation studies are used in the early stages of pharmaceutical development to ensure that the final products are stable. The goal of herbal drug stability testing is to give data on how much quality of the herbal products changes over time as a result of environmental variables like temperature, oxygen, and humidity, and to determine suggested storage settings, retest intervals, and shelf life. Objective - The current research focuses on the degradation profile of Stigmasterol, an active medicinal component in Chlorophytum borivilianum (Safed Musli), under several ICH mandated stress conditions. Material and Method - The stationary phase was TLC plates precoated with silica gel 60F-254.The solvent system is made up of toluene and ethyl acetate (8:2). This system produced well-separated Stigmasterol spots at Rf (0.40 ± 0.02). After derivatization by anisaldehyde sulphuric acid, stigmasterol was analysed at a wavelength of 550 nm. The Q1AR (parent drug stability testing guidelines) issued by the International ICH (Conference on Harmonization) were strictly followed. Conclusion - The current research establishes the degradation of stigmasterol under ICH-mandated stress conditions (i.e., Acid, Base, and Oxidative hydrolysis) using HPTLC. The drug breaks down in acidic and oxidative environments, but not in bases. The standard stigmasterol has an Rf value of 0.40± 0.02, in acidic conditions, the degradant is found on 1st day, 2nd day, 3rd day, 4th day and 5th day having an Rf value of 0.58 ± 0.02 and in the oxidative medium also, the degradant is found on 1st day ,2ndday ,3rdday ,4th day and 5th day having an Rf value of 0.17 ± 0.02. The method can be utilized as a stability indicator because it effectively separates the drug by its degradation products in acidic and oxidative conditions. Identification of degradants and impurities below the 0.1 percent limit is not required, as stated by ICH recommendations on impurities in new herbal drug products, unless possible impurities and degradants are predicted to be exceptionally powerful or dangerous and the highest daily dosage qualification threshold to be generally considered is < 2g per day 0.1 percent or 1 mg per day consumption (whichever is less) >2g per day 0.05 percent. Degradants obtained in the present study can be used as lead compounds for the novel drug discovery process and the biological activity of these compounds can also be established as ICH guidelines.