Development and Validation of LC-MSMS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials
Joint Authors
Chen, Yuyuan
Wu, Song
Yang, Qingyun
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-03-09
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Pantoprazole sodium (PPZS) is a selective proton pump inhibitor used in the prevention and treatment of gastric acid-related diseases.
Six potentially genotoxic impurities (PGIs) are involved in 5-difluoromethoxy-2-mercapto-1H-benzimidazole (DMBZ), which is the starting material of PPZS.
To date, no suitable method has yet been developed for PGI separation and quantification at the threshold of toxicological concern levels.
In this study, a sensitive and reliable liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative analysis of six PGIs in DMBZ according to the guidelines of the International Council for Harmonization (ICH).
The calibration curves showed good linearity within the studied range, and the correlation coefficient of fitting exceeded 0.998 for each impurity.
The sensitivity of the proposed method was in the range of 0.6–10.0 ng/mL.
Good recoveries were observed in the range of 94.32%–107.43% with RSD values below 6.5%.
Quantitative analysis of impurities in substance batches of DMBZ showed the high efficiency of the developed method at a low level.
Hence, the proposed method is practical and useful in the detection and qualification of PGIs in DMBZ and may be applied to ensure the safe use of PPZS in clinical treatment.
American Psychological Association (APA)
Chen, Yuyuan& Wu, Song& Yang, Qingyun. 2020. Development and Validation of LC-MSMS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials. Journal of Analytical Methods in Chemistry،Vol. 2020, no. 2020, pp.1-8.
https://search.emarefa.net/detail/BIM-1174791
Modern Language Association (MLA)
Chen, Yuyuan…[et al.]. Development and Validation of LC-MSMS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials. Journal of Analytical Methods in Chemistry No. 2020 (2020), pp.1-8.
https://search.emarefa.net/detail/BIM-1174791
American Medical Association (AMA)
Chen, Yuyuan& Wu, Song& Yang, Qingyun. Development and Validation of LC-MSMS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials. Journal of Analytical Methods in Chemistry. 2020. Vol. 2020, no. 2020, pp.1-8.
https://search.emarefa.net/detail/BIM-1174791
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1174791