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Development and validation of analytical methods for characterization and quantification of Ertapenem sodium in lyophilized powder for injectable solution

Grant number: 13/12959-0
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): May 01, 2014
Effective date (End): September 30, 2017
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal Investigator:Hérida Regina Nunes Salgado
Grantee:Tahisa Marcela Pedroso
Home Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
Associated scholarship(s):15/03412-3 - Development and validation of an analytical method by hydrophilic interaction chromatography: HILIC friendly to the environment for analyses to Ertapenem sodium in lyophilized powder for injectable solution, BE.EP.DR

Abstract

Antimicrobial agents have unquestionable importance in the control of many diseases; however the constant preoccupation with the evolution of resistant microorganisms is increasing. Carbapenems are ²-lactam antimicrobials broad-spectrum resistant to hydrolysis of ²-lactamases, which is the main mechanism of resistance of many microorganisms. Ertapenem sodium is a synthetic antimicrobial agent of the class of carbapenems commercially available in the form of lyophilized powder for solution for injection, under the commercial name INVANZ® by Merck Sharp & Dohme. It shows action against Gram-negative, Gram-positive, aerobic and anaerobic microorganisms. Its mechanism of action results from inhibition of cell wall synthesis. Studies on antimicrobial activity, pharmacokinetics and pharmacodynamics for ertapenem are presented in the literature, however there are few studies reported related to the development of analytical methods applied to quality control. Therefore, research involving the development of methodologies for the characterization and quantification of this drug, giving priority for ease of implementation, reduced analysis time and reducing the use of organic solvents, are of high importance to ensure the quality of the marketed product since sustainability has been discussed and encouraged globally. Thereat, this work proposes the development of new methods for analysis of ertapenem in pharmaceutical formulation using spectrophotometry in the regions of ultraviolet and infrared, high performance liquid chromatography, microbiological assay and capillary electrophoresis, as well as conducting studies of polymorphic forms that will be held at the National University of Cordoba - Argentina.

Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
PEDROSO, TAHISA MARCELA; VAN SCHEPDAEL, ANN; NUNES SALGADO, HERIDA REGINA. Application of the Principles of Green Chemistry for the Development of a New and Sensitive Method for Analysis of Ertapenem Sodium by Capillary Electrophoresis. INTERNATIONAL JOURNAL OF ANALYTICAL CHEMISTRY, 2019. Web of Science Citations: 0.
PEDROSO, TAHISA M.; MEDEIROS, ANA C. D.; SALGADO, HERIDA R. N. RP-HPLC x HILIC chromatography for quantifying ertapenem sodium with a look at green chemistry. Talanta, v. 160, p. 745-753, NOV 1 2016. Web of Science Citations: 8.
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
PEDROSO, Tahisa Marcela. Desenvolvimento e validação de métodos analíticos para caracterização e quantificação de ertapenem sódico em pó liofilizado para solução injetável. 2017. 238 f. Doctoral Thesis - Universidade Estadual Paulista "Júlio de Mesquita Filho" Faculdade de Ciências Farmacêuticas..

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