Radio stability Assessment of 2-acetoxybenzoic acid via HPLC and HRMS
DOI:
https://doi.org/10.53555/jc64b453Keywords:
stability-indicating Methods, Aspirin, HPLC Method Development, Forced Degradation Studies, Ionizing Radiation, Impurity Profiling, High-Resolution Mass Spectrometry (HRMS), Regulatory guidelines (ICH Q1 (R2)).Abstract
The stability of pharmaceutical formulations is a critical aspect of ensuring their safety, efficacy, and quality throughout their intended shelf life. This study presents a comprehensive approach to evaluating the stability of aspirin, a widely used pharmaceutical agent, by developing and validating a stability-indicating high-performance liquid chromatography (HPLC) method. The research investigates the effects of ionizing radiation on aspirin, focusing on impurity profiling through advanced high-resolution mass spectrometry (HRMS).
Aspirin was subjected to forced degradation under hydrolysis, oxidation, photolysis, thermal stress, and ionizing radiation, including gamma and neutron exposures. The HPLC method was optimized using a reverse-phase C18 column and a tailored mobile phase to ensure the effective separation and quantification of aspirin and its degradation products. HRMS enabled precise identification and characterization of impurities, providing insights into degradation pathways.
The study highlights the significant impact of ionizing radiation on the chemical stability of aspirin, leading to the formation of unique degradation products. These findings have critical implications for Pharmaceuticals exposed to extreme environments, such as during space missions or sterilization processes. The research underscores the importance of integrating stability-indicating methods and impurity profiling in pharmaceutical quality control to ensure drug safety and efficacy under diverse conditions. This work contributes to the broader understanding of drug stability and supports the development of robust analytical methods for regulatory compliance.
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