دورية أكاديمية
Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC-MS/MS.
| العنوان: | Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC-MS/MS. |
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| المؤلفون: | Erkol S; Faculty of Art and Science, Department of Chemistry, Yildiz Technical University, Esenler, Istanbul, Türkiye., Güleli M; R&D Center, World Medicine İlaç San. Tic. A.Ş, Bağcılar, İstanbul, Türkiye., Çalışkan C; R&D Center, World Medicine İlaç San. Tic. A.Ş, Bağcılar, İstanbul, Türkiye., Kocaoba S; Faculty of Art and Science, Department of Chemistry, Yildiz Technical University, Esenler, Istanbul, Türkiye. |
| المصدر: | European journal of mass spectrometry (Chichester, England) [Eur J Mass Spectrom (Chichester)] 2024 Feb; Vol. 30 (1), pp. 76-83. Date of Electronic Publication: 2023 Nov 30. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: SAGE Publishing Country of Publication: England NLM ID: 101124748 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1751-6838 (Electronic) Linking ISSN: 14690667 NLM ISO Abbreviation: Eur J Mass Spectrom (Chichester) Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2017- : London, U.K. : SAGE Publishing Original Publication: Chichester, West Sussex, U.K. : IM Publications, c2000- |
| مواضيع طبية MeSH: | Liquid Chromatography-Mass Spectrometry* , Pulmonary Disease, Chronic Obstructive*, Humans ; Chromatography, Liquid/methods ; Tiotropium Bromide ; Tandem Mass Spectrometry/methods ; Bronchodilator Agents ; Chromatography, High Pressure Liquid/methods |
| مستخلص: | Tiotropium Bromide is a long-acting bronchodilator that is used in the treatment of chronic obstructive pulmonary disease (COPD) and asthma bronchodilator or bronchiolitis, which are substances that expand the bronchi and reduce resistance in the respiratory tract and increase airflow to the lungs. For Tiotropium Bromide found in inhaler capsules to treat COPD, determining the relevant impurities G and H, which are not UV active, is crucial. For this purpose, a new and sensitive liquid chromatography triple-quadrupole mass spectrometry (LC-MS/MS) detection with electrospray ionization by using multiple reaction monitoring in the positive mode method was developed and validated. The identity of the compounds was supported by using LC-Q/TOF. All chromatographic studies were performed with a Zorbax Eclipse XDB-C8 (150 mm x 4.6 mm, 5.0 µm) column with a total injection time of 13 min at a flow rate of 0.4 ml/min as a gradient. The limit of detection (LOD) and limit of quantitation (LOQ) in the current study range were determined as 1.0 ppb and 2.5 ppb, respectively. The results of the validation parameters following the ICH Q2(R1) guideline were determined within the acceptance criteria. Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. |
| فهرسة مساهمة: | Keywords: LC-MS/MS; LC-Q/TOF; Tiotropium bromide; impurity G; impurity H; method validation |
| المشرفين على المادة: | XX112XZP0J (Tiotropium Bromide) 0 (Bronchodilator Agents) |
| تواريخ الأحداث: | Date Created: 20231201 Date Completed: 20240125 Latest Revision: 20240125 |
| رمز التحديث: | 20240125 |
| DOI: | 10.1177/14690667231217879 |
| PMID: | 38037337 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1751-6838 |
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| DOI: | 10.1177/14690667231217879 |