Banca de DEFESA: FABIANE MARIA FERNANDES NEVES

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : FABIANE MARIA FERNANDES NEVES
DATE: 25/11/2022
TIME: 09:00
LOCAL: Plataforma RNP
TITLE:

Development and validation of an analytical method using HPLC for the quality control of tenofovir disoproxil fumarate and emtricitabine.

KEY WORDS:

Anti-HIV Drugs; High-Performance Liquid Chromatography; Emtricitabine; Tenofovir Disoproxil Fumarate; Analytical Validation.

PAGES: 62
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUBÁREA: Análise e Controle de Medicamentos
SUMMARY:

Pre-exposure prophylaxis (PrEP) to the HIV virus (Human Immunodeficiency Virus - HIV) with the use of Truvada, consists of the combination of the fixed-dose oral formulation of the drugs emtricitabine (FTC) 200 mg and tenofovir disoproxil fumarate (TDF) 300 mg. This antiretroviral drug, whose main objective is to prevent the virus from seroconverting in the human organism, was approved by the Food Drug Administration (FDA) and made available in Brazil in 2017 by the Brazilian Unified Health System. However, analytical methodologies developed for the quality assurance of Active Pharmaceutical Ingredients (API) of Truvada are limited. The purpose of the present theoretical-experimental study was to analyze and elaborate a literature review of existing analytical and bioanalytical methods in the literature for the antiretroviral drugs FTC and TDF. In addition, in the experimental phase, a rapid isocratic reverse-phase analytical method was developed and validated by High-Performance Liquid Chromatography (HPLC) with simultaneous UV detection of the active drugs. The study demonstrated adequate validation parameters among sensitivity, linearity, precision, accuracy, and limits of detection and quantification, meeting the main national and international regulatory guides. Therefore, the method proved to be suitable for use in routine analysis for active pharmaceutical ingredients or tablets.

 

COMMITTEE MEMBERS:
Presidente - 2053589 - EDITH CRISTINA LAIGNIER CAZEDEY
Interna - 1281669 - RENATA BIEGELMEYER DA SILVA RAMBO
Externo à Instituição - MARTIN STEPPE - UFRGS