应力降解研究和已验证的稳定性指示密度计方法的开发，用于估计散装和胶囊剂型中的α-硫辛酸

IF 1.7 4区化学 Q3 CHEMISTRY, ANALYTICAL

Acta Chromatographica Pub Date : 2022-05-18 DOI:10.1556/1326.2022.01034

S. Srivastava, S. Dhaneshwar, N. Kawathekar

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引用次数: 1

摘要

以预涂硅胶60F254薄层色谱板为固定相，甲苯∶氯仿∶甲醇∶甲酸（5:3:1:0.05；v/v/v/v）为流动相，建立并验证了α-硫辛酸（ALA）散装和胶囊剂型的精密、灵敏、特异、准确的稳定性指示密度计法。所开发的方法在衍生后提供了紧凑的α-硫辛酸斑点（Rf 0.28±0.05），在80–400纳克/斑点范围内提供了良好的线性，相关系数为0.998。检测值和定量值分别为18.022和54.612纳克/点。ALA进行了应力降解研究，共分解了13种降解产物。因此，根据ICH指南，所提出的方法提供了良好的结果，可用于鉴别、常规定量测定以及监测ALA在散装和胶囊中的稳定性。

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Stress degradation studies and development of validated stability indicating densitometric method for estimation of alpha lipoic acid in bulk and capsule dosage form

A precise, sensitive, specific and accurate stability indicating densitometric method was developed and validated for alpha-lipoic acid (ALA) in bulk and capsule dosage form. The study employed pre-coated silica gel 60F254 TLC plates as stationary phase and toluene: chloroform: methanol: formic acid (5:3:1:0.05; v/v/v/v) as mobile phase. The developed method furnished compact spots of alpha-lipoic acid (Rf 0.28 ± 0.05) after derivatization, offered good linearity in range 80–400 ng/spot with correlation coefficient of 0.998. The values for detection and quantitation were found 18.022 and 54.612 ng/spot respectively. ALA was subjected to stress degradation studies and total 13 degradation products were resolved. Thus, the proposed method offered good results according to ICH guidelines, and can be used for identification, routine quantitative determination as well as for monitoring the stability of ALA in bulk and in capsules.

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来源期刊

Acta Chromatographica 化学-分析化学

CiteScore

4.00

自引率

0.00%

发文量

审稿时长

2.3 months

期刊介绍： Acta Chromatographica Open Access Acta Chromatographica publishes peer-reviewed scientific articles on every field of chromatography, including theory of chromatography; progress in synthesis and characterization of new stationary phases; chromatography of organic, inorganic and complex compounds; enantioseparation and chromatography of chiral compounds; applications of chromatography in biology, pharmacy, medicine, and food analysis; environmental applications of chromatography; analytical and physico-chemical aspects of sample preparation for chromatography; hyphenated and combined techniques; chemometrics and its applications in separation science.