ABSTRACT Introduction: Swertiamarin (SWE) is a bioactive secoiridoid glycoside derived from the medicinal plant Enicostemma littorale and is a promising candidate for anti‐diabetic therapy. However, SWE have shown poor bioavailability and stability concerns. Objective: This study aims to systematically investigate the stability of swertiamarin under controlled stress conditions according to International Council for Harmonisation (ICH) guidelines. Materials and methods: A stability‐indicating high‐performance liquid chromatography (HPLC) method was developed and validated. Forced degradation of SWE was performed under heat (60°C), oxidative, and hydrolytic (acidic, basic, neutral) stress conditions. Results: SWE underwent rapid degradation under hydrolytic stress, degrading completely within 20 minutes in base and within 2 hours in acid. These stress conditions produced four degradation products namely 5‑hydroxysecologanolic acid, loganic acid, sweritranslactone C, and sweritranslactone B. Overall, SWE was stable at 60°C and significantly degraded under other tested stress conditions such as acidic, basic, aqueous neutral and oxidative conditions. Conclusion: The findings highlight the instability of SWE under stress environments and underscore the necessity of protective formulation strategies and controlled storage conditions to ensure its pharmaceutical efficacy in therapeutic applications.
Nanaware et al. (Thu,) studied this question.
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