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Development and Validation of LC-MSMS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials
المؤلفون المشاركون
Chen, Yuyuan
Wu, Song
Yang, Qingyun
المصدر
Journal of Analytical Methods in Chemistry
العدد
المجلد 2020، العدد 2020 (31 ديسمبر/كانون الأول 2020)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2020-03-09
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1174791
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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