دورية أكاديمية
Novel method for monitoring of carcinogenic impurity of N-nitrosamine in nizatidine pharmaceutical products using ultra high-pressure liquid chromatography triple quadrupole mass spectrometry.
| العنوان: | Novel method for monitoring of carcinogenic impurity of N-nitrosamine in nizatidine pharmaceutical products using ultra high-pressure liquid chromatography triple quadrupole mass spectrometry. |
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| المؤلفون: | Dhorajiya S; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, Gujarat, India., Goswami J; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, Gujarat, India., Dudhatra B; School of Applied Sciences and Technology, Gujarat Technological University, Ahmedabad, Gujarat, India., Thummar K; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, Gujarat, India. |
| المصدر: | Rapid communications in mass spectrometry : RCM [Rapid Commun Mass Spectrom] 2024 Oct 15; Vol. 38 (19), pp. e9884. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: John Wiley And Sons Ltd Country of Publication: England NLM ID: 8802365 Publication Model: Print Cited Medium: Internet ISSN: 1097-0231 (Electronic) Linking ISSN: 09514198 NLM ISO Abbreviation: Rapid Commun Mass Spectrom Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Chichester : John Wiley And Sons Ltd Original Publication: London, UK : Heyden, c1987- |
| مواضيع طبية MeSH: | Tandem Mass Spectrometry*/methods , Nizatidine*/chemistry , Nizatidine*/analysis , Drug Contamination* , Nitrosamines*/analysis , Nitrosamines*/chemistry , Carcinogens*/analysis , Carcinogens*/chemistry, Chromatography, High Pressure Liquid/methods ; Limit of Detection ; Reproducibility of Results ; Diethylnitrosamine/analysis ; Diethylnitrosamine/chemistry ; Linear Models ; Tablets/chemistry |
| مستخلص: | Nitrosamine compounds pose a significant concern as potential carcinogens, prompting heightened scrutiny from regulatory bodies, particularly regarding their presence in pharmaceuticals. The detection of unacceptable levels of N-nitrosodiethylamine (NDMA) in ranitidine has led to widespread recalls, driving interest in alternative medications such as nizatidine, which shares a similar pharmacological class and is used to treat various gastrointestinal conditions. Despite fewer reports on NDMA levels in nizatidine, its structural similarity to ranitidine, characterized by a tertiary amine, underscores the potential for NDMA formation. Addressing the analytical challenges associated with nitrosamine detection, this study focuses on developing and validating an ultra-high pressure liquid chromatography triple quadrupole mass spectrometry (UHPLC-MS/MS) method for quantifying NDMA in both nizatidine active pharmaceutical ingredients and tablet formulations. Method validation adheres to International Council for Harmonisation recommendations, with a demonstrated linear range of 0.25-100 ng/mL for NDMA, exhibiting excellent linearity (regression coefficient >0.999) and efficient recovery rates ranging from 95.98% to 109.57%. The method shows high sensitivity, with limits of detection and quantification of 0.25 and 0.5 ng/mL, respectively. The developed UHPLC-MS/MS method offers a simple, precise, accurate, and selective approach for monitoring NDMA levels in nizatidine formulations available in Australia, promising enhanced sensitivity and specificity with limits of quantification in the ppb and sub-ppb ranges. (© 2024 John Wiley & Sons Ltd.) |
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| معلومات مُعتمدة: | GTU/IQAC/SMS/Sanctionletter/2021/7488 Gujarat Technological University |
| المشرفين على المادة: | P41PML4GHR (Nizatidine) 0 (Nitrosamines) 0 (Carcinogens) 3IQ78TTX1A (Diethylnitrosamine) 0 (Tablets) |
| تواريخ الأحداث: | Date Created: 20240812 Date Completed: 20240812 Latest Revision: 20240812 |
| رمز التحديث: | 20240813 |
| DOI: | 10.1002/rcm.9884 |
| PMID: | 39129244 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1097-0231 |
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| DOI: | 10.1002/rcm.9884 |