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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

Analysis of the Genotoxic Impurity S-(+)-Epichlorohydrin Contained in (S)-Oxiracetam using Gas Chromatography

Author(s): Jinbiao Li, Dandan Li, Wenjing Lu, Jinhui Wu* and Hong Dong*

Volume 18, Issue 6, 2022

Published on: 26 April, 2022

Page: [642 - 649] Pages: 8

DOI: 10.2174/1573412918666220128092202

Price: $65

Abstract

Background: (S)-oxiracetam has shown better efficacy than racemic oxiracetam in the trial. However, there is no report on the method used to detect the genotoxic impurity of S-(+)- epichlorohydrin(S-(+)-ECH) that may be contained in (S)-oxiracetam.

Objective: Here, we have proposed and verified a detailed analysis method for the (S-(+)-ECH) impurity in (S)-oxiracetam using a gas chromatography(GC) system.

Methods: The chromatography system includes a Supelco DB-624 capillary column. The initial column temperature was 50°C, kept for 4 minutes, and then increased to 220°C at a rate of 10°C/min for 4 minutes. Nitrogen was used as the carrier gas. The constant flow rate was 3.8 mL/min, the split ratio was 10:1, the injection port temperature was maintained at 200°C, and a hydrogen flame ionization detector was used. S-(+)-ECH was analyzed in detail by this analysis method, and three different batches of samples were measured. The GC system was used for verification.

Results: The method verification results included the system suitability, specificity, sensitivity, accuracy, precision, and the good correlation coefficient between peak responses and concentrations were over 0.990.

Conclusion: The method proposed in this study is the most detailed GC method currently used for the analysis of S-(+)-ECH impurities in (S)-oxiracetam. The proposed method has the advantages of fast, convenience, low cost, etc. It provides a reference method for quality control of genotoxic impurity of (S)-oxiracetam.

Keywords: (S)-oxiracetam, S-(+)-epichlorohydrin, GC, genotoxic impurities analysis, chromatogram, Epichlorohydrin (ECH).

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Graphical Abstract

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