Stability-Indicating Densitometric Analysis of Evogliptin Tartrate in Bulk and Tablet Dosage Form.

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Shruti Srivastava, Suneela Dhaneshwar, Neha Kawathekar
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引用次数: 0

Abstract

Background: Evogliptin tartrate is a novel dipeptidyl peptidase (DPP-4) inhibitor very recently introduced into the market as an oral hypoglycemic drug.

Objective: The literature review has revealed no reports of stability-indicating analytical methods so far for evogliptin tartrate. Thus, the goal of this study was to develop and validate a stability-indicating high-performance thin-layer chromatography (HPTLC) method for evogliptin tartrate in bulk and tablet dosage form.

Method: For the study, precoated plates of silica gel 60F254 were used as stationary phase and acetonitrile-water-formic acid (30:8:2, v/v/v) was used as a developing system. The densitometric scanning was performed at 270 nm, and the method was validated as per International Council for Harmonisation (ICH) guidelines for accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). Evogliptin was subjected to forced degradation studies and was exposed to various stress conditions such as acid/base hydrolysis, oxidation, thermal stress, and UV light.

Results: The developed method furnished compact spots of evogliptin (Rf 0.62 ± 0.05) and was linear in the concentration range of 1-5 µg/spot. The lowest detection and quantitation values were found to be 0.331 and 1.003 µg/spot, respectively, and % recovery was found to be 101.09. The low RSD values (below 2%) for intra-day (% RSD 1.86) and inter-day (% RSD 1.43) precision studies demonstrated the preciseness of the developed method.

Conclusions: All the validation parameters were found to be within the acceptable range prescribed by ICH guidelines, indicating that the developed method was accurate, precise, selective, and reproducible. A total of five degradation products were resolved under various stress conditions.

Highlights: The proposed method has a promising application commercially for identification, routine quantitative determination, and monitoring of stability of the evogliptin tartrate in bulk and tablet dosage forms to guarantee its safety, efficacy, and quality. Moreover, the developed method will also help in formulation development and in determining the appropriate storage conditions.

酒石酸依格列汀散装和片剂稳定性指示密度分析。
背景:酒石酸埃沃列汀是一种新型的二肽基肽酶(DPP-4)抑制剂,作为一种口服降血糖药物最近被引入市场。目的:文献综述显示,迄今为止,尚无酒石酸埃沃列汀稳定性指示分析方法的报告。因此,本研究的目的是开发和验证一种用于本体和片剂酒石酸埃沃列汀的稳定性指示高效薄层色谱(HPTLC)方法。方法:本研究以硅胶预涂板60F254为固定相,乙腈-水-甲酸(30:8:2,v/v/v)为展开系统。密度计扫描在270 nm,并且该方法根据国际协调理事会(ICH)关于准确性、精密度、检测限(LOD)和定量限(LOQ)的指南进行了验证。Evogliptin进行了强制降解研究,并暴露于各种应力条件下,如酸/碱水解、氧化、热应力和紫外线。结果:所开发的方法提供了埃沃列汀的紧密斑点(Rf 0.62 ± 0.05),并且在1-5的浓度范围内是线性的 µg/点。最低检测和定量值分别为0.331和1.003 µg/点,回收率为101.09。日内(%RSD 1.86)和日间(%RSD 1.43)精密度研究的低RSD值(低于2%)证明了所开发方法的精密度。结论:所有验证参数均在ICH指南规定的可接受范围内,表明所开发的方法是准确、准确、选择性和可重复的。在各种应力条件下总共分解了五种降解产物。亮点:该方法在本体和片剂中酒石酸埃沃列汀的鉴别、常规定量测定和稳定性监测方面具有良好的商业应用前景,以保证其安全性、有效性和质量。此外,所开发的方法也将有助于配方开发和确定适当的储存条件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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