Quality by design applied to olanzapine and quetiapine LC-MS/MS bioanalysis.

Autor: da Mota Castelo Branco D; Pharmaceutical and Cosmetics Development Center-NUDFAC, Federal University of Pernambuco, Avenida Professor Artur de Sá, s/n, Cidade Universitária, Recife, PE 50.730-420, Brazil., Bedor NCTC; B&S Innovation in Development and Analysis of Pharmaceutical Products, Rua Costa Sepulveda, 749, Engenho do Meio, Recife, PE 50.730-260, Brazil., Silva CS; Department of Chemical Engineering, Federal University of Pernambuco, Avenida Professor Artur de Sá, s/n, Cidade Universitária, Recife, PE 50.730-420, Brazil., Bedor DCG; Pharmaceutical and Cosmetics Development Center-NUDFAC, Federal University of Pernambuco, Avenida Professor Artur de Sá, s/n, Cidade Universitária, Recife, PE 50.730-420, Brazil.; B&S Innovation in Development and Analysis of Pharmaceutical Products, Rua Costa Sepulveda, 749, Engenho do Meio, Recife, PE 50.730-260, Brazil., Pimentel MF; Department of Chemical Engineering, Federal University of Pernambuco, Avenida Professor Artur de Sá, s/n, Cidade Universitária, Recife, PE 50.730-420, Brazil., de Santana DP; Pharmaceutical and Cosmetics Development Center-NUDFAC, Federal University of Pernambuco, Avenida Professor Artur de Sá, s/n, Cidade Universitária, Recife, PE 50.730-420, Brazil.
Jazyk: angličtina
Zdroj: Journal of chromatographic science [J Chromatogr Sci] 2020 Jan 23; Vol. 58 (2), pp. 117-126.
DOI: 10.1093/chromsci/bmz083
Abstrakt: One major challenge in quantifying drugs in biological matrices is to manage interfering compounds. A technique such liquid chromatography coupled to mass spectrometry in tandem (LC-MS/MS) is especially suitable for this application due to its high sensitivity and selectivity in detecting low concentrations of analytes in a complex system. Due to the complexity of LC-MS/MS systems, a number of experimental parameters must be optimized to provide an adequate separation and detection of the analyte. In the present work, a design of experiments approach was developed to optimize an LC-MS/MS-based bioanalytical method to extract olanzapine (OLZ) and quetiapine (QTP) from human plasma. Three steps for the optimization process were conducted: central composite face-centered design to optimize chromatographic parameters (Step 1), ionization in mass spectrometry (Step 2) and a full 32 factorial design to optimize analyte extraction conditions (Step 3). After the optimization process, resolutions and QTP and OLZ retention time (2.3 and 4, respectively) were optimum with pH of 4.7 and 85.5% of acetonitrile for the chromatographic step. Mass spectrometry optimization step provided an increase of (±50%) in the average peak area with high signal-to-noise relationship for the analytes studied. The proposed extraction method was 70% more efficient than the initial method for all drugs analyzed.
(© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje