Appliance of the ICH Guidelines: Forced Degradation Studies on Abafungin and Development of Validated Stability Indicating Method by 1st Order Derivative Spectroscopy

Background: The presented study is a stability indicating simple, precise and accurate 1st order UV derivative spectroscopic method that is being studied under the different stated International Council for Harmonization (ICH) Guidelines for the forced degradation and establishes a validated method for Abafungin and its main degradants in the active pharmaceutical ingredients (API) and the marketed formulations. Materials and Methods: Adhering to the ICH guidelines the analytical parameters viz. linearity, range, precision, recovery, robustness and ruggedness were validated. The method was based on thorough stress testing with acid, base, thermal, photolytic and oxidative degradations. Results: It was found that a linear response is present in the concentration range of 5-50 μg/mL at 242 nm. The % relative standard deviation (RSD) for precision studies of Intraday and Interday were <1.2% and <1.9% respectively. Conclusion: The appropriateness of the developed method was tested by analyzing the marketed cream of Abafungin and the thorough forced degradations studies was able to predict the stability of Abafungin in the marketed formulation. The method is found to be unambiguous to both the drug and its degradants.