Comprehensive Degradation Analysis of Swertiamarin: Stability-Indicating Assay and Structure Elucidation of Degradation Products.

IF 2.6 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS
Phytochemical Analysis Pub Date : 2026-04-01 Epub Date: 2026-02-12 DOI:10.1002/pca.70053
Bhakti Nanaware, Pranav Shevkar, Venkata Gopal Ede, Ashutosh Goswami, Abhijeet S Kate
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引用次数: 0

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.

獐牙菜黄素的综合降解分析:稳定性测定及降解产物的结构解析。
摘要:獐牙菜苦苷(SWE)是从药用植物獐牙菜花中提取的一种具有生物活性的环烯醚萜苷类化合物,是一种很有前景的抗糖尿病药物。然而,SWE表现出较差的生物利用度和稳定性问题。目的:根据国际统一理事会(ICH)的指导方针,系统考察獐牙菜苦苷在受控应激条件下的稳定性。材料和方法:建立并验证了稳定性指示的高效液相色谱法。SWE在高温(60°C)、氧化和水解(酸性、碱性、中性)胁迫条件下进行强制降解。结果:SWE在水解胁迫下降解迅速,在碱中20分钟降解完全,在酸中2小时降解完全。这些胁迫条件产生了4种降解产物,即5 -羟基次生酚酸、马哲酸、獐牙菜酯内酯C和獐牙菜酯内酯b。总体而言,SWE在60°C下是稳定的,在酸性、碱性、水中性和氧化条件下,SWE的降解效果显著。结论:该研究结果提示了SWE在应激环境下的不稳定性,并强调了保护性配方策略和控制储存条件的必要性,以确保其在治疗应用中的药效。
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来源期刊
Phytochemical Analysis
Phytochemical Analysis 生物-分析化学
CiteScore
6.00
自引率
6.10%
发文量
88
审稿时长
1.7 months
期刊介绍: Phytochemical Analysis is devoted to the publication of original articles concerning the development, improvement, validation and/or extension of application of analytical methodology in the plant sciences. The spectrum of coverage is broad, encompassing methods and techniques relevant to the detection (including bio-screening), extraction, separation, purification, identification and quantification of compounds in plant biochemistry, plant cellular and molecular biology, plant biotechnology, the food sciences, agriculture and horticulture. The Journal publishes papers describing significant novelty in the analysis of whole plants (including algae), plant cells, tissues and organs, plant-derived extracts and plant products (including those which have been partially or completely refined for use in the food, agrochemical, pharmaceutical and related industries). All forms of physical, chemical, biochemical, spectroscopic, radiometric, electrometric, chromatographic, metabolomic and chemometric investigations of plant products (monomeric species as well as polymeric molecules such as nucleic acids, proteins, lipids and carbohydrates) are included within the remit of the Journal. Papers dealing with novel methods relating to areas such as data handling/ data mining in plant sciences will also be welcomed.
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