Derivatization-Based Novel Chromatographic and Spectrophotometric Methods for the Simultaneous Determination of Gymnemic Acid and Resveratrol in Antidiabetic Polyherbal Formulation.

IF 1.3 4区 化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-02-02 DOI:10.1093/chromsci/bmad084
Dhruv Joshi, Charmy Kothari, Nrupesh Patel
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Abstract

Herbal medicine is widely used for the treatment and prevention of various ailments, highlighting the importance of ensuring its consistency and quality. This research focuses on the simultaneous detection of Gymnemic acid (GYM) and Resveratrol (RES) in an antidiabetic polyherbal formulation as no reported method exists for their simultaneously detection. The objective of this study is to develop and validate novel derivatization-based spectrometric and HPTLC methods for the simultaneous determination of GYM and RES. The spectrophotometric method involved derivatization of GYM with benzoyl chloride, followed by measurement of absorbance at 349 nm an isoabsorptive point. The HPTLC method utilized post derivatization with vanillin-sulfuric acid, and its separation was achieved on pre-coated silica gel 60GF254 using chloroform:methanol:glacial acetic acid (13:4:0.1, v/v/v) as mobile phase and estimated at 575 nm. The developed method exhibits linearity, accuracy, precision, LOD, LOQ, specificity and robustness in accordance with the ICH Q2 (R1) guideline. The percent assay of GYM and RES in the marketed capsule formulation was statistically compared using an unpaired t-test, resulting in a range of 99.51-102.65%. These indicate no significant difference between the proposed method and the marketed formulation. Therefore, both novel methods can be interchangeably used for quality control of GYM and RES in polyherbal formulations.

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基于衍生化的新型色谱和分光光度法同时测定抗糖尿病复方中药制剂中裸子酸和白藜芦醇的含量。
草药被广泛用于治疗和预防各种疾病,强调了确保其一致性和质量的重要性。本研究主要研究抗糖尿病复方中药制剂中裸子酸(GYM)和白藜芦醇(Resveratrol)的同时检测方法,目前尚无相关报道。本研究的目的是建立并验证一种新的衍生化光谱法和HPTLC同时测定GYM和res的方法。分光光度法是将GYM与苯甲酰氯衍生,然后在349nm处测量吸光度。hplc法采用香草素-硫酸后衍生化,以氯仿:甲醇:冰醋酸(13:4:1 . 0,v/v/v)为流动相,在60GF254预包被硅胶上进行分离,测定波长为575 nm。该方法具有线性、准确度、精密度、LOD、LOQ、特异性和稳健性,符合ICH Q2 (R1)指南。采用非配对t检验对上市胶囊制剂中GYM和RES的百分含量进行统计比较,结果为99.51 ~ 102.65%。这些表明所建议的方法与市场上销售的配方之间没有显著差异。因此,这两种新方法可互换用于复方中GYM和RES的质量控制。
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来源期刊
CiteScore
2.90
自引率
7.70%
发文量
94
审稿时长
5.6 months
期刊介绍: The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.
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