دورية أكاديمية
Empagliflozin: Validation of Stability-Indicating LC Method and in silico Toxicity Studies.
| العنوان: | Empagliflozin: Validation of Stability-Indicating LC Method and in silico Toxicity Studies. |
|---|---|
| المؤلفون: | da Silva AT; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., Brabo GR; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., Porto DDS; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., da Silva Jonco J; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil.; Programa de Pós-Graduação em Ciências Farmacêuticas, Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., Bajerski L; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., Paula FR; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil.; Programa de Pós-Graduação em Ciências Farmacêuticas, Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil., Paim CS; Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade; Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil.; Programa de Pós-Graduação em Ciências Farmacêuticas, Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970, Uruguaiana (RS), Brasil. |
| المصدر: | Journal of chromatographic science [J Chromatogr Sci] 2024 Feb 02; Vol. 62 (2), pp. 132-139. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 0173225 Publication Model: Print Cited Medium: Internet ISSN: 1945-239X (Electronic) Linking ISSN: 00219665 NLM ISO Abbreviation: J Chromatogr Sci Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2012- > : Oxford : Oxford University Press Original Publication: Niles Il : Preston Technical Abstracts |
| مواضيع طبية MeSH: | Chromatography, High Pressure Liquid*/methods , Benzhydryl Compounds* , Glucosides*, Chromatography, Liquid ; Acetonitriles |
| مستخلص: | A new stability-indicating liquid chromatography method was developed for the quantification of empagliflozin and two synthetic impurities. The chromatographic conditions included Spherisorb® RP-18 column (150 × 4.6 mm, 5 μm) with a PDA detector, using acetonitrile and formic acid (pH 4.0) as mobile phase in gradient elution and flow-rate of 1.2 mL·min-1. The gradient increasing from 51 to 100% acetonitrile until 11.00 min, followed by decreasing the solvent from 100% to the initial ratio from 11.01 to 15.00 min. The method was validated according to International Council of Harmonization guidelines. The LOD and LOQ values for impurities A and B were 35 and 15 ng·mL-1, respectively, (for LOD) and 115 and 35 ng.mL-1, respectively (for LOQ). The method was linear in the range of 80-140, 115-1150 and 35-350 ng·mL-1 for EMPA, impurities A and B, respectively, and the correlation coefficient were > 0.999 in all situations, indicating the method good linearity. The developed method showed a good recovery for empagliflozin and added impurities. The method has proven to be precise, demonstrated values less than 2.0% to empagliflozin and 5.0% to synthetic impurities, robust and selective with no interference from other products in the determination of analytes. The in silico toxicity prediction suggested that the impurities do not present any toxicity risk for the parameters evaluated. (© The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.) |
| معلومات مُعتمدة: | PDA 2018 and 2019 Federal University of Pampa; CNPQ 457629 2014/2 CNPq |
| المشرفين على المادة: | HDC1R2M35U (empagliflozin) 0 (Acetonitriles) 0 (Benzhydryl Compounds) 0 (Glucosides) |
| تواريخ الأحداث: | Date Created: 20221231 Date Completed: 20240209 Latest Revision: 20240209 |
| رمز التحديث: | 20240209 |
| DOI: | 10.1093/chromsci/bmac106 |
| PMID: | 36585772 |
| قاعدة البيانات: | MEDLINE |
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