Analysis of the Genotoxic Impurity S-(+)-Epichlorohydrin Contained in (S)-Oxiracetam using Gas Chromatography / Jinbiao Li, Dandan Li, Wenjing Lu, Jinhui Wu, Hong Dong
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Current pharmaceutical analysis - 18(2022), 6, Seite 8 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li, Jinbiao [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Umfang: |
1 Online-Ressource (8 p) |
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| Förderinstitution / Projekttitel: |
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KFL011170573 |
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| 245 | 1 | 0 | |a Analysis of the Genotoxic Impurity S-(+)-Epichlorohydrin Contained in (S)-Oxiracetam using Gas Chromatography |c Jinbiao Li, Dandan Li, Wenjing Lu, Jinhui Wu, Hong Dong |
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| 520 | |a 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 | ||
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| 700 | 1 | |a Lu, Wenjing |e verfasserin |4 aut | |
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| 700 | 1 | |a Dong, Hong |e verfasserin |4 aut | |
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