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一种用于测定托吡酯的更绿色的稳定性指示高效薄层色谱法

A Greener Stability-Indicating High-Performance Thin-Layer Chromatography Approach for the Estimation of Topiramate.

作者信息

Alqarni Mohammed H, Shakeel Faiyaz, Mahdi Wael A, Foudah Ahmed I, Aljarba Tariq M, Alshehri Sultan, Ghoneim Mohammed M, Alam Prawez

机构信息

Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.

Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.

出版信息

Materials (Basel). 2022 Feb 25;15(5):1731. doi: 10.3390/ma15051731.

Abstract

Despite various reported analytical methods for topiramate (TPM) analysis, greener analytical approaches are scarce in literature. As a consequence, the objective of the current research is to design a normal-phase stability-indicating high-performance thin-layer chromatography (SI-HPTLC) methodology for TPM analysis in marketed tablet dosage forms that is rapid, sensitive, and greener. TPM was derivatized densitometrically and analyzed at 423 nm in visible mode with anisaldehyde-sulfuric acid as the derivatizing agent. The greener SI-HPTLC technique was linear in the 30-1200 ng band range. In addition, the suggested SI-HPTLC methodology for TPM analysis was simple, rapid, cheaper, precise, robust, sensitive, and environmentally friendly. The greener SI-HPTLC method was able to detect TPM along with its degradation products under acid, base, and oxidative degradation conditions. However, no TPM degradation was recorded under thermal and photolytic stress conditions. TPM contents in commercial tablet dosage forms were recorded as 99.14%. Using 12 different principles of green analytical chemistry, the overall analytical GREEnness (AGREE) score for the greener SI-HPTLC method was calculated to be 0.76, confirming the proposed normal-phase SI-HPTLC method's good greener nature. Overall, these results demonstrated that the suggested SI-HPTLC technique for TPM measurement in pharmaceutical products was reliable and selective.

摘要

尽管已有多种报道的用于托吡酯(TPM)分析的方法,但文献中更环保的分析方法却很稀缺。因此,本研究的目的是设计一种正相稳定性指示高效薄层色谱法(SI-HPTLC),用于市售片剂剂型中TPM的分析,该方法快速、灵敏且更环保。TPM采用密度测定法衍生化,以茴香醛-硫酸为衍生剂,在423nm可见光模式下进行分析。这种更环保的SI-HPTLC技术在30 - 1200ng条带范围内呈线性。此外,所建议的用于TPM分析的SI-HPTLC方法简单、快速、成本低、精确、稳健、灵敏且环保。这种更环保的SI-HPTLC方法能够在酸、碱和氧化降解条件下检测TPM及其降解产物。然而,在热和光解应激条件下未记录到TPM降解。市售片剂剂型中TPM的含量记录为99.14%。根据绿色分析化学的12条不同原则,计算出这种更环保的SI-HPTLC方法的总体分析绿色度(AGREE)评分为0.76,证实了所提出的正相SI-HPTLC方法具有良好的环保特性。总体而言,这些结果表明所建议的用于药品中TPM测量的SI-HPTLC技术可靠且具有选择性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0fe/8911037/897840530824/materials-15-01731-g001.jpg

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