A Novel Validated GC–MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine.
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| Title: | A Novel Validated GC–MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine. |
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| Authors: | Papadasu, Narayanareddy1,2 (AUTHOR), Kotanka, Ramakrishnareddy2 (AUTHOR) k.ramakrishnareddy@reva.edu.in, Pannala, Raghuram1 (AUTHOR) |
| Source: | Journal of Chromatographic Science. May/Jun2024, Vol. 62 Issue 5, p399-405. 7p. |
| Subjects: | Azidothymidine, Electron impact ionization, Ethanes, Electron sources, Amines |
| Abstract: | A novel method has been developed for the estimation of N-Nitroso dimethyl amine impurities (NDMA) and N-Nitroso diethyl amine (NDEA) in Zidovudine by using Gas chromatograph Triple Quadrupole Mass with Liquid autosampler (GC–MS/MS) and the method is validated as per International Conference on Harmonization recommendations. Sample analysis was executed for Zidovudine by developed method. Both NDMA and NDEA were detected in below quantitation limit for the Zidovudine batches. Efficient chromatographic separation was achieved on a DB-WAX 30 m length × 0.25 mm internal diameter, 0.5-μm film thickness, Triple quad-8040 GC–MS/MS. Quantification was carried out at Triple quad electron ionization source was at a column flow of 1.5 mL/min at a column oven temperature 50°C. The precision was in the range of 0.9–2.5% for NDMA and 0.8–2.3% for NDEA, and regression analysis shows as r value (correlation coefficient) of is >0.99. This method is capable to detect the NDMA and NDEA impurities in Zidovudine at a level of 0.006 ppm for limit of detection and 0.018 ppm for limit of quantitation with respect to test concentration of 66.66 mg/mL. [ABSTRACT FROM AUTHOR] |
| Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Engineering Source |
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| Header | DbId: egs DbLabel: Engineering Source An: 177611360 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: A Novel Validated GC–MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Papadasu%2C+Narayanareddy%22">Papadasu, Narayanareddy</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kotanka%2C+Ramakrishnareddy%22">Kotanka, Ramakrishnareddy</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> k.ramakrishnareddy@reva.edu.in</i><br /><searchLink fieldCode="AR" term="%22Pannala%2C+Raghuram%22">Pannala, Raghuram</searchLink><relatesTo>1</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Journal+of+Chromatographic+Science%22">Journal of Chromatographic Science</searchLink>. May/Jun2024, Vol. 62 Issue 5, p399-405. 7p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Azidothymidine%22">Azidothymidine</searchLink><br /><searchLink fieldCode="DE" term="%22Electron+impact+ionization%22">Electron impact ionization</searchLink><br /><searchLink fieldCode="DE" term="%22Ethanes%22">Ethanes</searchLink><br /><searchLink fieldCode="DE" term="%22Electron+sources%22">Electron sources</searchLink><br /><searchLink fieldCode="DE" term="%22Amines%22">Amines</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: A novel method has been developed for the estimation of N-Nitroso dimethyl amine impurities (NDMA) and N-Nitroso diethyl amine (NDEA) in Zidovudine by using Gas chromatograph Triple Quadrupole Mass with Liquid autosampler (GC–MS/MS) and the method is validated as per International Conference on Harmonization recommendations. Sample analysis was executed for Zidovudine by developed method. Both NDMA and NDEA were detected in below quantitation limit for the Zidovudine batches. Efficient chromatographic separation was achieved on a DB-WAX 30 m length × 0.25 mm internal diameter, 0.5-μm film thickness, Triple quad-8040 GC–MS/MS. Quantification was carried out at Triple quad electron ionization source was at a column flow of 1.5 mL/min at a column oven temperature 50°C. The precision was in the range of 0.9–2.5% for NDMA and 0.8–2.3% for NDEA, and regression analysis shows as r value (correlation coefficient) of is >0.99. This method is capable to detect the NDMA and NDEA impurities in Zidovudine at a level of 0.006 ppm for limit of detection and 0.018 ppm for limit of quantitation with respect to test concentration of 66.66 mg/mL. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1093/chromsci/bmae008 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 7 StartPage: 399 Subjects: – SubjectFull: Azidothymidine Type: general – SubjectFull: Electron impact ionization Type: general – SubjectFull: Ethanes Type: general – SubjectFull: Electron sources Type: general – SubjectFull: Amines Type: general Titles: – TitleFull: A Novel Validated GC–MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Papadasu, Narayanareddy – PersonEntity: Name: NameFull: Kotanka, Ramakrishnareddy – PersonEntity: Name: NameFull: Pannala, Raghuram IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 05 Text: May/Jun2024 Type: published Y: 2024 Identifiers: – Type: issn-print Value: 00219665 Numbering: – Type: volume Value: 62 – Type: issue Value: 5 Titles: – TitleFull: Journal of Chromatographic Science Type: main |
| ResultId | 1 |
