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−1 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.

Highlights

  • Publisher’s Note: MDPI stays neutralTopiramate (TPM) is a sulfamate-substituted derivative of the monosaccharide D-fructose, which is used as an antiepileptic drug in the treatment of different kinds of seizures and epileptic disorders [1]

  • CyHex and ethyl acetate (EtAc) were tested as the greener mobile phases for the formation of a suitab bandAsfor

  • Method were recorded as 0.48–0.97% at three different Quality Control (QC) levels for the inter-day variation. These results suggest the precision of the suggested SI-high-performance thin-layer chromatography (HPTLC) method for TPM analysis in its marketed tablet dosage forms

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Summary

Introduction

Topiramate (TPM) is a sulfamate-substituted derivative of the monosaccharide D-fructose, which is used as an antiepileptic drug in the treatment of different kinds of seizures and epileptic disorders [1]. It acts on the central nervous system by blocking voltage-sensitive sodium channels and increasing the activity of γ-amino butyric acid [2,3]. The analysis of TPM is possible via derivatization using different derivatizing agents. Various pharmaceutical assays have been reported for the determination of TPM in different dosage forms and physiological fluids, such as plasma, serum, blood, and human breast milk. The analysis of TPM using the specrofluorimetry method was possible via derivatization using a 4-chloro-7nitrobenzofuran-2-oxo-1,3-diazole (NBD-Cl) derivatizing agent [5]. A colorimetry method with regard to jurisdictional claims in published maps and institutional affiliations

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